Pain, PostoperativeNCT05969509
Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy
A study testing progressive relaxation exercise in people with Pain, Postoperative, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare in health conditions. The main questions it aims to answer are: Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients undergoing laparoscopic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Who experienced laparoscopic cholecystectomy surgery as planned for the first time
- Who volunteered to participate in the research
- 18 years and over
- Whose mental state is healthy
- Without vision, hearing and speech problems
- Patients who know Turkish were included in the study.
Who cannot join
- Who have previously practiced progressive relaxation exercises
- Someone with communication problems
- Health problems that prevent the practice of progressive relaxation exercises (Epilepsy, bipolar disorder, schizophrenia, fever, infection, etc. ) is
- Patients who were not willing to participate in the study were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Yüzüncü Yıl University Dursun Odabaş Medical Center
Van, 65000
Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi, (0432) 215 04 70, hastane@yyu.edu.tr
About this study
The goal of this clinical trial is to compare in health conditions. The main questions it aims to answer are:
Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients undergoing laparoscopic cholecystectomy?
Read the detailed description
The purpose of our experimentally randomized controlled study, which researchers conducted in order to study the effect of progressive relaxation exercises on pain and bowel movements in patients undergoing laparoscopic cholecystectomy, is to reduce pain by intermittent application of progressive relaxation exercises to patients after surgery and to study the effect of exercise on bowel movements at an early stage.
after the necessary permissions have been obtained july- september dates, Van Yüzüncü yıl university Dursun Odabaş medical center, in the general surgery clinic , patients who agree to participate in the study and meet the sample selection criteria will be included in the study. Patient presentation form, bowel movement monitoring form and Visual Analog Scale (VAS) Pain Form will be used in the collection of research data.
- Conditions
- Pain, Postoperative
- Being tested
- progressive relaxation exercise
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups
| Study group | Role | What they receive |
|---|---|---|
| the group that performed relaxation exercises | Experimental | patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently Receives: Other: progressive relaxation exercise |
| the group that did not do relaxation exercises | No intervention | patients' postoperative pain and bowel movements will be evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Form
it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line
Measured: examination between 1-2 days until Decontamination from surgery
bowel movement monitoring form
It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.
Measured: examination between 1-2 days until Decontamination from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- two groups consisting of experimental and control groups performed cholecystectomy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şuheda Zorer, Ataturk University
- Investigators
- şuheda zorer, Principal investigator, van yüzüncü yıl university dursun odabaş medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969509
- Sponsor's protocol ID
- AtaturkU-SBF-SZ-01
- Status last verified
- Apr 2024
- First submitted
- 12 Jul 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zorer Yilmaz S, Gurcayir D. The Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2025 Oct;19(4):410-416. doi: 10.1016/j.anr.2025.08.004. Epub 2025 Sep 18.
PubMed 40975381
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05969509
- Acronym / sponsor ID
- AtaturkU-SBF-SZ-01
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
The goal of this clinical trial is to compare in health conditions. The main questions it aims to answer are:
Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients undergoing laparoscopic cholecystectomy?
Detailed description
The purpose of our experimentally randomized controlled study, which researchers conducted in order to study the effect of progressive relaxation exercises on pain and bowel movements in patients undergoing laparoscopic cholecystectomy, is to reduce pain by intermittent application of progressive relaxation exercises to patients after surgery and to study the effect of exercise on bowel movements at an early stage.
after the necessary permissions have been obtained july- september dates, Van Yüzüncü yıl university Dursun Odabaş medical center, in the general surgery clinic , patients who agree to participate in the study and meet the sample selection criteria will be included in the study. Patient presentation form, bowel movement monitoring form and Visual Analog Scale (VAS) Pain Form will be used in the collection of research data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups consisting of experimental and control groups performed cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| the group that performed relaxation exercises | Experimental | Other: progressive relaxation exercisepatients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently |
| the group that did not do relaxation exercises | No intervention | –patients' postoperative pain and bowel movements will be evaluated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Who experienced laparoscopic cholecystectomy surgery as planned for the first time
- Who volunteered to participate in the research
- 18 years and over
- Whose mental state is healthy
- Without vision, hearing and speech problems
Key exclusion criteria (4 listed)
- Who have previously practiced progressive relaxation exercises
- Someone with communication problems
- Health problems that prevent the practice of progressive relaxation exercises (Epilepsy, bipolar disorder, schizophrenia, fever, infection, etc. ) is
- Patients who were not willing to participate in the study were not included in the study.
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 relaxation exerciseapplying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups | Other | the group that performed relaxation exercises |
Primary outcome
Visual Analog Scale (VAS) Pain Form
Time frame: examination between 1-2 days until Decontamination from surgery
it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line
bowel movement monitoring form
Time frame: examination between 1-2 days until Decontamination from surgery
It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 40975381Zorer Yilmaz S, Gurcayir D. The Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2025 Oct;19(4):410-416. doi: 10.1016/j.anr.2025.08.004. Epub 2025 Sep 18.
- 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.
şuheda zorer principal investigator
van yüzüncü yıl university dursun odabaş medical center
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 relaxation exercise in people with Pain, Postoperative, run by Ataturk 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 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact şuheda zorer (05427336700, zorersuheda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Form (time frame: examination between 1-2 days until Decontamination from surgery). The study lists 2 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 NCT05969509, which also lists 1 linked publication.
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 16 Apr 2024.