Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients

NCT06920082 | Active Not Recruiting

• 1 other identifier: 2025/01-03
• 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 pancreatic and colon cancer patients receiving chemotherapy on sleep, fatigue, and pain.

Conditions

Pancreatic Cancer; Colon Cancer

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, 340340, Turkey (Türkiye)

Location

Related Publications (2)

• Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28.

  PMID: 38418943 RESULT

• 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

MeSH Terms

Conditions

Pancreatic Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

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: Principal Investigator

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: July 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)