<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04436705</url>
  </required_header>
  <id_info>
    <org_study_id>The University of Jordan</org_study_id>
    <nct_id>NCT04436705</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain</brief_title>
  <official_title>The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain Among Palliative Care Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial was designed to evaluate the effectiveness of the&#xD;
      Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in&#xD;
      patients receiving palliative care in Jordan.&#xD;
&#xD;
      The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do&#xD;
      not report a decrease in pain intensity levels and an improve in pain interferences with life&#xD;
      activities as a result of participating in PMR technique to a significant extent compared to&#xD;
      patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer&#xD;
      patients receiving palliative care report a decrease in pain intensity levels and an improve&#xD;
      in pain interferences with life activities as a result of participating in PMR technique to a&#xD;
      significant extent compared to patients who do not participate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2. Methods&#xD;
&#xD;
        1. Design:&#xD;
&#xD;
           This study was designed as an assessor-blinded, prospective, two parallel groups,&#xD;
           randomized, controlled trial.&#xD;
&#xD;
        2. Participants and setting:&#xD;
&#xD;
           Participants were recruited from palliative care outpatient clinics at King Hussein&#xD;
           Cancer Center in Amman, Jordan.&#xD;
&#xD;
           The sample size was calculated using statistical software package G* Power 3.0.10. Based&#xD;
           on α = 0.05, a power of 80%, and a medium effect size (Cohen's d = 0.50), the minimum&#xD;
           required sample for each group was 64 patients. To be conservative and avoid the&#xD;
           negative impact of attrition, the sample was increased to 150 patients for both groups;&#xD;
           hence 75 participants were required per group.&#xD;
&#xD;
        3. Randomization:&#xD;
&#xD;
           The list of potential patients was given weekly to the first author by palliative nurse&#xD;
           coordinator. The second author assessed the patients based on study inclusion criteria.&#xD;
           A total of fifteen patients were excluded due to not meeting the trial criteria (n=13)&#xD;
           and refusing to participate in the trial (n=2). The second author was not engaged in&#xD;
           study intervention divided remaining 150 patients into two groups (intervention group&#xD;
           (n=75), and control group (n=75)).&#xD;
&#xD;
           Participants were randomly allocated in a 1:1 ratio to PMR and control groups using a&#xD;
           computer-based minimization algorithm stratifying for gender, type of analgesics&#xD;
           (non-opioid or weak opioid). The second author informed the participants about the&#xD;
           results of randomization by providing labels coded either intervention or control group.&#xD;
           Training on PMR technique were done by the first author who was not blinded to study&#xD;
           groups. The participants were also not blinded to the study intervention due to the&#xD;
           nature of kind of study intervention. All evaluations were completed by a single data&#xD;
           collector who was blinded to study groups.&#xD;
&#xD;
           In this trial, the blinding condition of data collector was maintained by two steps: (1)&#xD;
           the first author informed the patients to not provide any information to the data&#xD;
           collector about their allocated group, and (2) the data collector reminded all the&#xD;
           patients to not reveal what group s/he was randomized to. Thus, the condition of&#xD;
           assessor-blind was confirmed in this trial by blinding the data collector. During the&#xD;
           study period, one participant in control group due to travel outside the country, and&#xD;
           one participant in intervention group due to lack of sufficient time withdrew from the&#xD;
           study. Thus, 148 participants completed the study (RMP group (n=74), and control group&#xD;
           (n=74)).&#xD;
&#xD;
        4. Procedures:&#xD;
&#xD;
           The participants received training on the PMR intervention in the palliative care&#xD;
           outpatient clinic in a quiet room with adequate light to make them feel relaxed during&#xD;
           the intervention. Training on the PMR intervention was delivered individually by face to&#xD;
           face. Patients in the intervention group were received instruction on PMR technique by&#xD;
           the first author who trained and experienced in the technique. The theoretical session&#xD;
           on the PMR took approximately 15 minutes. After the completion of the theoretical&#xD;
           session, the first author demonstrated the PMR technique, then the participants applied&#xD;
           the technique until they acquired the skill. Participants in intervention group received&#xD;
           totally 30 to 40 minutes training on PMR technique including theoretical and practical&#xD;
           sessions. Then, PMR booklets designed by the authors were given to the patients in&#xD;
           training sessions. Furthermore, the first author recorded PMR technique with a voice&#xD;
           recorder using her own voice, and the recorder file was downloaded on compact disc (CD).&#xD;
           Each participant was given a copy of the CD to practice PMR technique at home. The&#xD;
           intervention group continued the PMR daily for 20 minutes for a total of four weeks at&#xD;
           their home. All participants were warned not to take analgesics either orally sixty&#xD;
           minutes before or intravenously thirty minutes before the PMR technique. Daily reminder&#xD;
           phone calls or Short Message Service (SMS) were performed to remind participants for&#xD;
           practicing the technique and check their compliance with study protocol. Regarding to&#xD;
           control group, the patients were invited to the same room and completed the baseline&#xD;
           assessment. All participants received usual care for their pain during the study period&#xD;
           which contained only pharmacological interventions.&#xD;
&#xD;
           For ethical reasons, after completing this study, the participants in the control group&#xD;
           had the opportunity to receive study intervention. These data were not analyzed.&#xD;
&#xD;
        5. Data analysis:&#xD;
&#xD;
      Data were evaluated using Statistical Package for the Social Sciences (SPSS) version 22.0.&#xD;
      Patients' demographics, clinical characteristics, and BPI scores were represented as mean&#xD;
      values, standard deviations (SD), and percentages. Authors analyzed between-group differences&#xD;
      at baseline using t tests for continuous variables and Chi-square tests for categorical&#xD;
      variables. The comparisons between two groups in terms of BPI scores were made using&#xD;
      Mann-Whitney U test. Additionally, Friedman test was conducted to assess the data for&#xD;
      differences in BPI scores within-group. The level of significance was set at p &lt; 0.05 for all&#xD;
      tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer-related pain</measure>
    <time_frame>The BPI assessment was collected at baseline (T0) ( pre-intervention)</time_frame>
    <description>Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer-related pain</measure>
    <time_frame>The BPI assessment was collected at the end of PMR technique (4 weeks from T0)</time_frame>
    <description>Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer-related pain</measure>
    <time_frame>The BPI assessment was collected at 1-month follow-up (T2)</time_frame>
    <description>Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Cancer-Related Pain</condition>
  <arm_group>
    <arm_group_label>Progressive Muscle Relaxation (PMR) technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in intervention group continued Progressive Muscle Relaxation (PMR) technique daily for 20 minutes for a total of four weeks addition to usual care. The usual care consists of pharmacological interventions to manage Cancer-related pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group received only usual care for their pain during the study period. The usual care consists of pharmacological interventions to manage Cancer-related pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive Muscle Relaxation (PMR) technique</intervention_name>
    <description>The PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes.</description>
    <arm_group_label>Progressive Muscle Relaxation (PMR) technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18 years and older&#xD;
&#xD;
          -  diagnosed with cancer.&#xD;
&#xD;
          -  reported complaints of pain ≥1 on a 0-10 Numerical Rating Scale (NRS) in the 24 hours&#xD;
             before recruitment.&#xD;
&#xD;
          -  were treated with non-opioid or weak opioid analgesic.&#xD;
&#xD;
          -  had a Karnofsky Performance Scale Index ≥ 20.&#xD;
&#xD;
          -  had regular access to a telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of psychiatric illness, central nervous system tumors and musculoskeletal&#xD;
             disorders (because these conditions may limit the effectiveness of PMR technique).&#xD;
&#xD;
          -  using any type of complementary therapy during the trial period.&#xD;
&#xD;
          -  Patients who had no pain and were treated with strong opioid analgesics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ministry of Health, Amman, Jordan</last_name>
    <role>Study Director</role>
    <affiliation>MOH</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Huda Anshasi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cancer-related pain</keyword>
  <keyword>Progressive Muscle Relaxation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04436705
org study id: The University of Jordan
nct id: NCT04436705
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial was designed to evaluate the effectiveness of the
      Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in
      patients receiving palliative care in Jordan.

      The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do
      not report a decrease in pain intensity levels and an improve in pain interferences with life
      activities as a result of participating in PMR technique to a significant extent compared to
      patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer
      patients receiving palliative care report a decrease in pain intensity levels and an improve
      in pain interferences with life activities as a result of participating in PMR technique to a
      significant extent compared to patients who do not participate.
2. Methods

        1. Design:

           This study was designed as an assessor-blinded, prospective, two parallel groups,
           randomized, controlled trial.

        2. Participants and setting:

           Participants were recruited from palliative care outpatient clinics at King Hussein
           Cancer Center in Amman, Jordan.

           The sample size was calculated using statistical software package G* Power 3.0.10. Based
           on α = 0.05, a power of 80%, and a medium effect size (Cohen's d = 0.50), the minimum
           required sample for each group was 64 patients. To be conservative and avoid the
           negative impact of attrition, the sample was increased to 150 patients for both groups;
           hence 75 participants were required per group.

        3. Randomization:

           The list of potential patients was given weekly to the first author by palliative nurse
           coordinator. The second author assessed the patients based on study inclusion criteria.
           A total of fifteen patients were excluded due to not meeting the trial criteria (n=13)
           and refusing to participate in the trial (n=2). The second author was not engaged in
           study intervention divided remaining 150 patients into two groups (intervention group
           (n=75), and control group (n=75)).

           Participants were randomly allocated in a 1:1 ratio to PMR and control groups using a
           computer-based minimization algorithm stratifying for gender, type of analgesics
           (non-opioid or weak opioid). The second author informed the participants about the
           results of randomization by providing labels coded either intervention or control group.
           Training on PMR technique were done by the first author who was not blinded to study
           groups. The participants were also not blinded to the study intervention due to the
           nature of kind of study intervention. All evaluations were completed by a single data
           collector who was blinded to study groups.

           In this trial, the blinding condition of data collector was maintained by two steps: (1)
           the first author informed the patients to not provide any information to the data
           collector about their allocated group, and (2) the data collector reminded all the
           patients to not reveal what group s/he was randomized to. Thus, the condition of
           assessor-blind was confirmed in this trial by blinding the data collector. During the
           study period, one participant in control group due to travel outside the country, and
           one participant in intervention group due to lack of sufficient time withdrew from the
           study. Thus, 148 participants completed the study (RMP group (n=74), and control group
           (n=74)).

        4. Procedures:

           The participants received training on the PMR intervention in the palliative care
           outpatient clinic in a quiet room with adequate light to make them feel relaxed during
           the intervention. Training on the PMR intervention was delivered individually by face to
           face. Patients in the intervention group were received instruction on PMR technique by
           the first author who trained and experienced in the technique. The theoretical session
           on the PMR took approximately 15 minutes. After the completion of the theoretical
           session, the first author demonstrated the PMR technique, then the participants applied
           the technique until they acquired the skill. Participants in intervention group received
           totally 30 to 40 minutes training on PMR technique including theoretical and practical
           sessions. Then, PMR booklets designed by the authors were given to the patients in
           training sessions. Furthermore, the first author recorded PMR technique with a voice
           recorder using her own voice, and the recorder file was downloaded on compact disc (CD).
           Each participant was given a copy of the CD to practice PMR technique at home. The
           intervention group continued the PMR daily for 20 minutes for a total of four weeks at
           their home. All participants were warned not to take analgesics either orally sixty
           minutes before or intravenously thirty minutes before the PMR technique. Daily reminder
           phone calls or Short Message Service (SMS) were performed to remind participants for
           practicing the technique and check their compliance with study protocol. Regarding to
           control group, the patients were invited to the same room and completed the baseline
           assessment. All participants received usual care for their pain during the study period
           which contained only pharmacological interventions.

           For ethical reasons, after completing this study, the participants in the control group
           had the opportunity to receive study intervention. These data were not analyzed.

        5. Data analysis:

      Data were evaluated using Statistical Package for the Social Sciences (SPSS) version 22.0.
      Patients' demographics, clinical characteristics, and BPI scores were represented as mean
      values, standard deviations (SD), and percentages. Authors analyzed between-group differences
      at baseline using t tests for continuous variables and Chi-square tests for categorical
      variables. The comparisons between two groups in terms of BPI scores were made using
      Mann-Whitney U test. Additionally, Friedman test was conducted to assess the data for
      differences in BPI scores within-group. The level of significance was set at p < 0.05 for all
      tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Cancer-related pain
time frame: The BPI assessment was collected at baseline (T0) ( pre-intervention)
description: Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
measure: Cancer-related pain
time frame: The BPI assessment was collected at the end of PMR technique (4 weeks from T0)
description: Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
measure: Cancer-related pain
time frame: The BPI assessment was collected at 1-month follow-up (T2)
description: Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
arm group label: Progressive Muscle Relaxation (PMR) technique
arm group type: Experimental
description: Participants in intervention group continued Progressive Muscle Relaxation (PMR) technique daily for 20 minutes for a total of four weeks addition to usual care. The usual care consists of pharmacological interventions to manage Cancer-related pain.
arm group label: control
arm group type: No Intervention
description: control group received only usual care for their pain during the study period. The usual care consists of pharmacological interventions to manage Cancer-related pain.
intervention type: Other
intervention name: Progressive Muscle Relaxation (PMR) technique
description: The PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes.
arm group label: Progressive Muscle Relaxation (PMR) technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ministry of Health, Amman, Jordan
role: Study Director
affiliation: MOH
responsible party type: Principal Investigator
investigator affiliation: University of Jordan
investigator full name: Huda Anshasi
investigator title: Assistant Professor
mesh term: Cancer Pain
sharing ipd: No