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Active, Not Recruiting

NCT Number: NCT06920082

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Küçükçekmece, Istanbul, 340340, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Muscle Relaxation Exercises

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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"

  2. 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"

Sponsors and collaborators

Lead sponsor

Istanbul Sabahattin Zaim University

Other

Registry information

Official study title

Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients Receiving Chemotherapy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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