xml: <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/NCT05971641</url>
    </required_header>
    <id_info>
      <org_study_id>Bartın U</org_study_id>
      <nct_id>NCT05971641</nct_id>
    </id_info>
    <brief_title>The Effect of Progressive Relaxation Exercises on Postoperative Pain</brief_title>
    <official_title>The Effect of Progressive Relaxation Exercises on Postoperative Pain Intensity, Sleep Quality, and Recovery in Patients Undergoing Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bartın Unıversity</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bartın Unıversity</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The indicators of patient recovery in the postoperative period include sleep, physical&#xD;
        functionality, mental health, cognitive functionality, pain, and psychosocial functionality.&#xD;
  &#xD;
        This thesis aims to investigate the effects of progressive relaxation exercises on&#xD;
        postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee&#xD;
        arthroplasty.This study, designed as a randomized controlled experimental study, will be&#xD;
        conducted between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in&#xD;
        ZONGULDAK province, Turkey, among patients undergoing total knee arthroplasty. A total of 96&#xD;
        patients will be recruited based on the sample size calculated using G-power analysis.&#xD;
        Through block randomization, 48 patients will be assigned to the intervention group and 48&#xD;
        patients to the control group. Data will be collected using the Numeric Rating Scale for&#xD;
        pain, the Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep&#xD;
        quality and duration, the Postoperative Recovery Index, and a Patient Information Form.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: Knee osteoarthritis is observed in approximately 6% of adult individuals. Knee&#xD;
        osteoarthritis, which causes pain in individuals, often results in the impairment of their&#xD;
        daily lives. Total knee arthroplasty surgery is considered as the final method in the&#xD;
        treatment process of knee osteoarthritis. The indicators of patient recovery in the&#xD;
        postoperative period include sleep, physical functionality, mental health, cognitive&#xD;
        functionality, pain, and psychosocial functionality.&#xD;
  &#xD;
        Objective: This thesis aims to investigate the effects of progressive relaxation exercises on&#xD;
        postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee&#xD;
        arthroplasty.&#xD;
  &#xD;
        Method: This study, designed as a randomized controlled experimental study, will be conducted&#xD;
        between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in ZONGULDAK&#xD;
        province, Turkey, among patients undergoing total knee arthroplasty. A total of 96 patients&#xD;
        will be recruited based on the sample size calculated using G-power analysis. Through block&#xD;
        randomization, 48 patients will be assigned to the intervention group and 48 patients to the&#xD;
        control group. Data will be collected using the Numeric Rating Scale for pain, the&#xD;
        Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep quality and&#xD;
        duration, the Postoperative Recovery Index, and a Patient Information Form. The progressive&#xD;
        relaxation exercises Compact disc 8 (CD) prepared by the Turkish Psychologists Association&#xD;
        will be used for the patients' progressive relaxation exercise training. The data will be&#xD;
        analyzed using the Statistical Package for the Social Sciences (SPSS) program. The data will&#xD;
        be presented as numbers and percentages, means and standard deviations, and their&#xD;
        distribution will be assessed to determine whether parametric or non-parametric tests should&#xD;
        be employed for analysis. The data will be evaluated with a significance level of p&lt;0.05 and&#xD;
        a confidence interval of 95%.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>
      <intervention_model_description>Two group with a progressive relaxation exercise intervention group</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS):</measure>
      <time_frame>six day</time_frame>
      <description>The numeric rating scale is used to objectively measure pain and evaluate the effectiveness of pain management. It is utilized to determine patients' pain levels and guide treatment plans. In this scale, participants express their pain level with a specific numerical value. Typically, pain intensity is rated on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain. Participants are asked to indicate their pain intensity using a number based on their own experiences and perceptions. For example, a value between 0 and 2 may indicate mild pain, a value between 3 and 5 may indicate moderate pain, a value between 6 and 8 may indicate severe pain, and a value between 9 and 10 may indicate the most intense pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Richard Campbell Sleep Questionnaire (RCSQ):</measure>
      <time_frame>five day</time_frame>
      <description>The Richard Campbell Sleep Questionnaire (RCSQ), developed by Richards (1987), is a 6-item scale that assesses the depth of nighttime sleep, sleep onset latency, frequency of awakenings, duration of wakefulness upon awakening, sleep quality, and noise levels in the environment. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between '0-25' indicate very poor sleep, while scores between '76-100' indicate very good sleep. The scale's total score is based on the evaluation of 5 items, excluding the 6th item that assesses the noise level in the environment. As the score increases on the scale, the quality of patients' sleep also improves.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Recovery Index Scale (PRIS):</measure>
      <time_frame>four day</time_frame>
      <description>The Postoperative Recovery Index Scale (PRIS), developed by Butler et al. in 2012, is a scale that can be used within 30 days after surgery. It is suitable for different surgical procedures. PRIS consists of 5 subscales, which are psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-satisfaction symptoms. The scores of the items within each subscale are summed, arithmetic means are calculated, and subscale scores are determined. For the total score of PRIS, all 25 items are summed, and the arithmetic mean is taken. Higher scores obtained from the index reflect greater difficulties in postoperative recovery, while lower scores indicate easier postoperative recovery.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Arthroplasty</condition>
    <condition>Replacement</condition>
    <condition>Knee</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The experimental group is the one in which progressive relaxation exercises will be taught, and we will monitor the results in patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group is the one in which the service routine is implemented, and progressive relaxation exercises are not taught but monitored.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>progressive relaxation exercise</intervention_name>
      <description>Patients who undergo total knee replacement surgery in the experimental group will be taught progressive relaxation exercises. The exercise will last for 30 minutes and will be applied twice a day. Patients will wear a smart wristband. Patient Information Form, Numeric Rating Scale, Richard Campbell Sleep Quality Survey, and Postoperative Recovery Index Scale will be administered. The scales will be filled out for 5 days and will take approximately 10-15 minutes.</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and older,&#xD;
  &#xD;
            -  Without diagnosed mental disorders,&#xD;
  &#xD;
            -  Without visual, hearing, and speech impairments,&#xD;
  &#xD;
            -  Proficient in Turkish,&#xD;
  &#xD;
            -  Diagnosed with gonarthrosis and scheduled for total knee replacement,&#xD;
  &#xD;
            -  No postoperative complications following total knee replacement surgery,&#xD;
  &#xD;
            -  Literate with an educational level,&#xD;
  &#xD;
            -  Pain level of 4 or above on the NRS,&#xD;
  &#xD;
            -  Receiving analgesic treatment according to the clinical protocol,&#xD;
  &#xD;
            -  Ownership of a mobile device such as a smart phone or tablet capable of accessing&#xD;
               internet-based video content with the latest technology from any brand,&#xD;
  &#xD;
            -  Patients without diagnosed sleep problems will be included in the thesis study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Illiterate individuals,&#xD;
  &#xD;
            -  Under the age of 18,&#xD;
  &#xD;
            -  Having a condition that hinders communication,&#xD;
  &#xD;
            -  Referred from another center after surgery,&#xD;
  &#xD;
            -  Pain level of 4 or below on the NRS,&#xD;
  &#xD;
            -  Developing complications after total knee replacement surgery,&#xD;
  &#xD;
            -  Receiving analgesic treatment and methods outside of the clinical protocol,&#xD;
  &#xD;
            -  Not owning a mobile device such as a smart phone or tablet capable of accessing&#xD;
               internet-based video content with the latest technology from any brand,&#xD;
  &#xD;
            -  Having diagnosed sleep problems,&#xD;
  &#xD;
            -  Having diagnosed mental disorders, will be excluded from the scope of the thesis&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rumeysa Birkanım, Msc student</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bartın Unıversity</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rumeysa Birkanım, Msc student</last_name>
      <phone>+905458107793</phone>
      <email>rumeysa.birkanim67@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sevim Çelik, Professor</last_name>
      <phone>+905327832989</phone>
      <email>sevimakcel@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bartın Unıversity</investigator_affiliation>
      <investigator_full_name>Rumeysa Birkanım</investigator_full_name>
      <investigator_title>Nurse</investigator_title>
    </responsible_party>
    <keyword>Total Knee Replacement</keyword>
    <keyword>Progressive relaxation exercises</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971641
  org study id: Bartın U
  nct id: NCT05971641
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The indicators of patient recovery in the postoperative period include sleep, physical
        functionality, mental health, cognitive functionality, pain, and psychosocial functionality.
  
        This thesis aims to investigate the effects of progressive relaxation exercises on
        postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee
        arthroplasty.This study, designed as a randomized controlled experimental study, will be
        conducted between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in
        ZONGULDAK province, Turkey, among patients undergoing total knee arthroplasty. A total of 96
        patients will be recruited based on the sample size calculated using G-power analysis.
        Through block randomization, 48 patients will be assigned to the intervention group and 48
        patients to the control group. Data will be collected using the Numeric Rating Scale for
        pain, the Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep
        quality and duration, the Postoperative Recovery Index, and a Patient Information Form.
  Introduction: Knee osteoarthritis is observed in approximately 6% of adult individuals. Knee
        osteoarthritis, which causes pain in individuals, often results in the impairment of their
        daily lives. Total knee arthroplasty surgery is considered as the final method in the
        treatment process of knee osteoarthritis. The indicators of patient recovery in the
        postoperative period include sleep, physical functionality, mental health, cognitive
        functionality, pain, and psychosocial functionality.
  
        Objective: This thesis aims to investigate the effects of progressive relaxation exercises on
        postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee
        arthroplasty.
  
        Method: This study, designed as a randomized controlled experimental study, will be conducted
        between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in ZONGULDAK
        province, Turkey, among patients undergoing total knee arthroplasty. A total of 96 patients
        will be recruited based on the sample size calculated using G-power analysis. Through block
        randomization, 48 patients will be assigned to the intervention group and 48 patients to the
        control group. Data will be collected using the Numeric Rating Scale for pain, the
        Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep quality and
        duration, the Postoperative Recovery Index, and a Patient Information Form. The progressive
        relaxation exercises Compact disc 8 (CD) prepared by the Turkish Psychologists Association
        will be used for the patients' progressive relaxation exercise training. The data will be
        analyzed using the Statistical Package for the Social Sciences (SPSS) program. The data will
        be presented as numbers and percentages, means and standard deviations, and their
        distribution will be assessed to determine whether parametric or non-parametric tests should
        be employed for analysis. The data will be evaluated with a significance level of p<0.05 and
        a confidence interval of 95%.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two group with a progressive relaxation exercise intervention group
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group
  measure: Numeric Rating Scale (NRS):
  time frame: six day
  description: The numeric rating scale is used to objectively measure pain and evaluate the effectiveness of pain management. It is utilized to determine patients' pain levels and guide treatment plans. In this scale, participants express their pain level with a specific numerical value. Typically, pain intensity is rated on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain. Participants are asked to indicate their pain intensity using a number based on their own experiences and perceptions. For example, a value between 0 and 2 may indicate mild pain, a value between 3 and 5 may indicate moderate pain, a value between 6 and 8 may indicate severe pain, and a value between 9 and 10 may indicate the most intense pain.
  measure: Richard Campbell Sleep Questionnaire (RCSQ):
  time frame: five day
  description: The Richard Campbell Sleep Questionnaire (RCSQ), developed by Richards (1987), is a 6-item scale that assesses the depth of nighttime sleep, sleep onset latency, frequency of awakenings, duration of wakefulness upon awakening, sleep quality, and noise levels in the environment. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between '0-25' indicate very poor sleep, while scores between '76-100' indicate very good sleep. The scale's total score is based on the evaluation of 5 items, excluding the 6th item that assesses the noise level in the environment. As the score increases on the scale, the quality of patients' sleep also improves.
  measure: Postoperative Recovery Index Scale (PRIS):
  time frame: four day
  description: The Postoperative Recovery Index Scale (PRIS), developed by Butler et al. in 2012, is a scale that can be used within 30 days after surgery. It is suitable for different surgical procedures. PRIS consists of 5 subscales, which are psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-satisfaction symptoms. The scores of the items within each subscale are summed, arithmetic means are calculated, and subscale scores are determined. For the total score of PRIS, all 25 items are summed, and the arithmetic mean is taken. Higher scores obtained from the index reflect greater difficulties in postoperative recovery, while lower scores indicate easier postoperative recovery.
  arm group label: intervention group
  arm group type: Active Comparator
  description: The experimental group is the one in which progressive relaxation exercises will be taught, and we will monitor the results in patients.
  arm group label: control group
  arm group type: No Intervention
  description: The control group is the one in which the service routine is implemented, and progressive relaxation exercises are not taught but monitored.
  intervention type: Other
  intervention name: progressive relaxation exercise
  description: Patients who undergo total knee replacement surgery in the experimental group will be taught progressive relaxation exercises. The exercise will last for 30 minutes and will be applied twice a day. Patients will wear a smart wristband. Patient Information Form, Numeric Rating Scale, Richard Campbell Sleep Quality Survey, and Postoperative Recovery Index Scale will be administered. The scales will be filled out for 5 days and will take approximately 10-15 minutes.
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Rumeysa Birkanım, Msc student
  role: Principal Investigator
  affiliation: Bartın Unıversity
  last name: Rumeysa Birkanım, Msc student
  phone: +905458107793
  email: rumeysa.birkanim67@gmail.com
  last name: Sevim Çelik, Professor
  phone: +905327832989
  email: sevimakcel@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Bartın Unıversity
  investigator full name: Rumeysa Birkanım
  investigator title: Nurse
  mesh term: Pain, Postoperative
  sharing ipd: No