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

NCT06920095 | Enrolling By Invitation

• 1 other identifier: 2025/01-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma Patients

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  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

  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

  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

  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 Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)

• Pittsburgh Sleep Quality Index (PSQI)

  After the intervention (After progressive muscle relaxation exercises applied in week 6)

Study Arms (2)

Progressive muscle relaxation exercises

EXPERIMENTAL

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

Other: Progressive muscle relaxation exercises

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Progressive muscle relaxation exercises OTHER

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

Progressive muscle relaxation exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences,

Küçükçekmece, Istanbul, 34034, Turkey (Türkiye)

Location

Related Publications (2)

• Loh EW, Shih HF, Lin CK, Huang TW. Effect of progressive muscle relaxation on postoperative pain, fatigue, and vital signs in patients with head and neck cancers: A randomized controlled trial. Patient Educ Couns. 2022 Jul;105(7):2151-2157. doi: 10.1016/j.pec.2021.10.034. Epub 2021 Nov 3.

  PMID: 34785078 RESULT

• Tan L, Fang P, Cui J, Yu H, Yu L. Effects of progressive muscle relaxation on health-related outcomes in cancer patients: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2022 Nov;49:101676. doi: 10.1016/j.ctcp.2022.101676. Epub 2022 Oct 31.

  PMID: 36332326 RESULT

Study Officials

• Zülfünaz Özer, PhD

  İstanbul Sabahattin Zaim Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: March 3, 2025
• Primary Completion: April 7, 2025
• Study Completion: June 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)