<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/NCT04441827</url>
  </required_header>
  <id_info>
    <org_study_id>UPDBERCRFIDR</org_study_id>
    <nct_id>NCT04441827</nct_id>
  </id_info>
  <brief_title>Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy</brief_title>
  <official_title>The Study Aims to Evaluate Effectiveness of Pranayama and Deep Breathing Exercise in Reducing Fatigue and Insomnia in Patients Receiving Radiotherapy Due to Breast Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay University</source>
  <oversight_info>
    <has_dmc>Yes</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 study aims to evaluate the effectiveness of pranayama and deep breathing exercise in&#xD;
      reducing fatigue and insomnia in patients receiving radiotherapy due to breast cancer. The&#xD;
      randomized controlled interventional study was carried out with 60 patients divided into the&#xD;
      pranayama (20), deep breathing exercise (20) and control group (20). Data were collected with&#xD;
      the Piper Fatigue Scale (PFS), the Pittsburgh Sleep Quality Index (PSQI) and the Visual&#xD;
      Analog Scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study sample The study population consisted of patients diagnosed with breast cancer, who&#xD;
      received radiotherapy in the radiation oncology unit of a hospital in Ankara, between June&#xD;
      01, 2017 and January 31, 2019.&#xD;
&#xD;
      At least three additional volunteers (16%) for each group were added, considering monitoring&#xD;
      and data loss during the follow-up. Thus, the number of subjects was determined as 63&#xD;
      individuals (21 for each group).&#xD;
&#xD;
      Of the 63 patients, one wanted to interrupt the treatment and two did not want to continue in&#xD;
      the study, hence the study was concluded with 20 patients in each group (60 patients).&#xD;
&#xD;
      Instruments Fatigue Visual Analog Scale (VAS) Score Piper Fatigue Scale (PFS) Insomnia Visual&#xD;
      Analog Scale (VAS) Score Pittsburgh Sleep Quality Index (PSQI) Questionnaire on Patients'&#xD;
      Opinions of the Exercises Patients in the pranayama, deep breathing exercise and control&#xD;
      group were evaluated six times in terms of fatigue and insomnia VAS scores. PFS and PSQI were&#xD;
      evaluated once prior to and after the 25-day session of radiotherapy treatment.&#xD;
&#xD;
      Interventions Protocols for pranayama and deep breathing exercises were prepared Pranayama&#xD;
      and Deep Breathing Exercise Groups: The patients were taught pranayama and deep breathing&#xD;
      exercises by the researcher before the radiotherapy started. The patients were observed&#xD;
      performing these exercises for 10 minutes after each radiotherapy session (25 days)&#xD;
      accompanied by the researcher in a quiet room within the radiotherapy unit containing two&#xD;
      couches and a chair.&#xD;
&#xD;
      Control Group: The patients in this group did not receive any intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</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>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>Before radiotherapy</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>First week</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>Second week</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>Third week</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>Fourth week</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Visual Analog Scale (VAS) Score</measure>
    <time_frame>Fifth week</time_frame>
    <description>This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>Before radiotherapy</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>First week</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>Second week</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>Third week</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>Fourth week</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>İnsomnia Visual Analog Scale (VAS) Score</measure>
    <time_frame>Fifth week</time_frame>
    <description>The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Piper Fatique Scale</measure>
    <time_frame>Before radiotherapy</time_frame>
    <description>Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Piper Fatique Scale</measure>
    <time_frame>Fifth week</time_frame>
    <description>Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Before radiotherapy</time_frame>
    <description>Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Fifth week</time_frame>
    <description>Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Fatigue</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pranayama</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pranayama breathing exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep breathing exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep breathing exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>breathing exercise</intervention_name>
    <description>Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)</description>
    <arm_group_label>Deep breathing exercise</arm_group_label>
    <arm_group_label>Pranayama</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over the age of 18 years,&#xD;
&#xD;
          -  who underwent breast resection or modified radical mastectomy,&#xD;
&#xD;
          -  were planned for radiotherapy for the chest wall/breast and lymphatic area, had Stage&#xD;
             II-III breast cancer according to the TNM (Tumor diameter, Node, Metastasis)&#xD;
             classification system,&#xD;
&#xD;
          -  had a hemoglobin (HgB) level of 10 gm/dL and above,&#xD;
&#xD;
          -  scored 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale&#xD;
&#xD;
          -  who agreed to participate in the study were included in the sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having any problems that would prevent communication,&#xD;
&#xD;
          -  having stage IV breast cancer according to the TNM classification system,&#xD;
&#xD;
          -  using opioids or sedating drugs,&#xD;
&#xD;
          -  scoring above 1 on the ECOG Performance Scale,&#xD;
&#xD;
          -  having psychiatric illnesses,&#xD;
&#xD;
          -  taking yoga/pranayama/deep breathing exercise lessons before or having done these&#xD;
             exercises prior to diagnosis,&#xD;
&#xD;
          -  having recurrent breast cancer&#xD;
&#xD;
          -  being unable to perform the exercises due to physical inability/respiratory distress.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Yildirim Beyazıt University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 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>KTO Karatay University</investigator_affiliation>
    <investigator_full_name>Fatma Gündoğdu</investigator_full_name>
    <investigator_title>Principal İnvestigator</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Pranayama</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Breathing exercises</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Fatigue</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/NCT04441827
org study id: UPDBERCRFIDR
nct id: NCT04441827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the effectiveness of pranayama and deep breathing exercise in
      reducing fatigue and insomnia in patients receiving radiotherapy due to breast cancer. The
      randomized controlled interventional study was carried out with 60 patients divided into the
      pranayama (20), deep breathing exercise (20) and control group (20). Data were collected with
      the Piper Fatigue Scale (PFS), the Pittsburgh Sleep Quality Index (PSQI) and the Visual
      Analog Scale (VAS).
Study sample The study population consisted of patients diagnosed with breast cancer, who
      received radiotherapy in the radiation oncology unit of a hospital in Ankara, between June
      01, 2017 and January 31, 2019.

      At least three additional volunteers (16%) for each group were added, considering monitoring
      and data loss during the follow-up. Thus, the number of subjects was determined as 63
      individuals (21 for each group).

      Of the 63 patients, one wanted to interrupt the treatment and two did not want to continue in
      the study, hence the study was concluded with 20 patients in each group (60 patients).

      Instruments Fatigue Visual Analog Scale (VAS) Score Piper Fatigue Scale (PFS) Insomnia Visual
      Analog Scale (VAS) Score Pittsburgh Sleep Quality Index (PSQI) Questionnaire on Patients'
      Opinions of the Exercises Patients in the pranayama, deep breathing exercise and control
      group were evaluated six times in terms of fatigue and insomnia VAS scores. PFS and PSQI were
      evaluated once prior to and after the 25-day session of radiotherapy treatment.

      Interventions Protocols for pranayama and deep breathing exercises were prepared Pranayama
      and Deep Breathing Exercise Groups: The patients were taught pranayama and deep breathing
      exercises by the researcher before the radiotherapy started. The patients were observed
      performing these exercises for 10 minutes after each radiotherapy session (25 days)
      accompanied by the researcher in a quiet room within the radiotherapy unit containing two
      couches and a chair.

      Control Group: The patients in this group did not receive any intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: Before radiotherapy
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: First week
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: Second week
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: Third week
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: Fourth week
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: Fatigue Visual Analog Scale (VAS) Score
time frame: Fifth week
description: This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: Before radiotherapy
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: First week
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: Second week
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: Third week
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: Fourth week
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: İnsomnia Visual Analog Scale (VAS) Score
time frame: Fifth week
description: The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
measure: Piper Fatique Scale
time frame: Before radiotherapy
description: Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
measure: Piper Fatique Scale
time frame: Fifth week
description: Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
measure: Pittsburgh Sleep Quality Index
time frame: Before radiotherapy
description: Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas
measure: Pittsburgh Sleep Quality Index
time frame: Fifth week
description: Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas
arm group label: Control
arm group type: No Intervention
description: Usual care
arm group label: Pranayama
arm group type: Experimental
description: Pranayama breathing exercise
arm group label: Deep breathing exercise
arm group type: Experimental
description: Deep breathing exercise
intervention type: Other
intervention name: breathing exercise
description: Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)
arm group label: Deep breathing exercise
arm group label: Pranayama
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: KTO Karatay University
investigator full name: Fatma Gündoğdu
investigator title: Principal İnvestigator
mesh term: Breast Neoplasms
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Fatigue
sharing ipd: No