Pancreatic CancerNCT06920082
Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients
A study testing Progressive muscle relaxation exercises in people with Pancreatic Cancer and Colon Cancer, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Colon Cancer
- What is being tested?
- Progressive muscle relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Küçükçekmece, Istanbul, 340340
About this study
Official title: Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients Receiving Chemotherapy
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.
Read the detailed description
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.
- Conditions
- Pancreatic Cancer, Colon Cancer
- Being tested
- Progressive muscle relaxation exercises
- Medical subject headings
- Pancreatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exercisesOther
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation exercises | Experimental | A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks Receives: Other: Progressive muscle relaxation exercises |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the intervention (After progressive muscle relaxation exercises applied in week 6)
Secondary outcomes (2)
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"
Measured: 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"
Measured: After the intervention (After progressive muscle relaxation exercises applied in week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Mar 2025
- Primary completion7 Apr 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz Özer, PhD, Principal investigator, İstanbul Sabahattin Zaim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920082
- Sponsor's protocol ID
- 2025/01-03
- Status last verified
- Feb 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38418943Loh 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.
PubMed 34785078
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06920082
- Acronym / sponsor ID
- 2025/01-03
- Conditions
- Pancreatic Cancer, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation exercises | Experimental | Other: Progressive muscle relaxation exercisesA total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxation exercisesA total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks. | Other | Progressive muscle relaxation exercises |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 38418943Toraman 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.
- Results publication: PubMed 34785078Loh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zülfünaz Özer, PhD principal investigator
İstanbul Sabahattin Zaim Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation exercises in people with Pancreatic Cancer and Colon Cancer, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.