Progressive Muscle Relaxation Exercises on Sleep, Fatigue, Pain in Lymphoma Patients

April 2, 2025 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University

Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Lymphoma Patients

With regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. Therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to lymphoma patients on sleep, fatigue, and pain.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Küçükçekmece, İstanbul, Turkey, 34034
        • Istanbul Sabahattin Zaim University, Faculty of Health Sciences,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being over 18 years of age
  • Being able to communicate adequately
  • Not having a psychiatric problem
  • Those who are determined by a physician to have no physical obstacle to exercise
  • Individuals who can use technological devices
  • Patients who have had at least 3 cycles

Exclusion Criteria:

  • Those with communication problems
  • Those with psychiatric problems
  • Patients doing any exercise
  • Individuals with phones that do not have a voice recording feature
  • Individuals with phones that do not have a WhatsApp feature

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Routine maintenance will be applied
Experimental: Progressive muscle relaxation exercises
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.
Other: Progressive muscle relaxation exercises
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
Visual Analog Scale
Time Frame: After the intervention (After progressive muscle relaxation exercises applied in week 6)
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
After the intervention (After progressive muscle relaxation exercises applied in week 6)
The Piper Fatigue Scale
Time Frame: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.
Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
The Piper Fatigue Scale
Time Frame: After the intervention (After progressive muscle relaxation exercises applied in week 6)
It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.
After the intervention (After progressive muscle relaxation exercises applied in week 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
The PSQI is a valid and consistent survey comprising 19 questions to assess the quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients' subjective sleep quality, sleep delay, use of sleeping medication and dysfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score of ≤5 indicates "good sleep", and a score of>5 indicates "poor sleep"
Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: After the intervention (After progressive muscle relaxation exercises applied in week 6)
The PSQI is a valid and consistent survey comprising 19 questions to assess the quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients' subjective sleep quality, sleep delay, use of sleeping medication and dysfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score of ≤5 indicates "good sleep", and a score of>5 indicates "poor sleep"
After the intervention (After progressive muscle relaxation exercises applied in week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Sabahattin Zaim University

Investigators

  • Principal Investigator: Zülfünaz Özer, PhD, İstanbul Sabahattin Zaim Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

April 7, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/01-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Nonre

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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