- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2025-03-03
2025-04-07
2025-07-31
60
NCT06920082
Istanbul Sabahattin Zaim University
Istanbul Sabahattin Zaim University
INTERVENTIONAL
Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer 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 pancreatic and colon cancer patients receiving chemotherapy on sleep, fatigue, and pain.
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-02 | N/A | 2025-04-02 |
2025-04-02 | N/A | 2025-04-09 |
2025-04-09 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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
|
| NO_INTERVENTION: Control group Routine maintenance will be applied |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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) | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
