Cholecystectomy, LaparoscopicNCT06495411
Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy
A study testing pranayama- and deep breathing- in people with Cholecystectomy, Laparoscopic, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- pranayama- and deep breathing-
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shoulder pain after elective laparoscopic cholecystectomy surgery patients,
- No hearing-speech problems that would hinder communication,
- No cognitive-mental problems,
- Not having any psychiatric disease,
- No sleep disorder
- Patients who have not previously attended courses on breathing exercises and yoga,
- All volunteers who agreed to participate in the study were included in the study.
Who cannot join
- Admitted to the intensive care unit in the early postoperative period,
- Extra surgical intervention (hernia repair, etc.),
- During laparoscopic cholecystectomy, patients undergoing open cholecystectomy patients were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Effect of Pranayama and Deep Breathing Exercises on Shoulder Pain and Sleep Quality After Laparoscopic Cholecystectomy"
This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.
Read the detailed description
The data were collected by the researcher by face-to-face interview method at SBU Van Training and Research Hospital General Surgery Clinics. Necessary information was given to healthcare professionals in the clinics where the research would be conducted, and the lists of patients who would undergo surgery were followed. Data collection started in the preoperative period, and the data collection phase ended when the patient was discharged after the surgery.
To collect pranayama, deep breathing and control group data, the researcher identified patients who were scheduled to undergo laparoscopic cholecystectomy surgery in general surgery services on a daily basis and met the sampling criteria. In the hospital where the research was conducted, laparoscopic cholecystectomy surgeries were performed excluding emergency surgeries.
It is performed electively and patient education is provided on the day of surgery. Patients are taken into surgery according to the surgery list determined the day before.
It was determined by randomization whether the patients participating in the study would be in the control or experimental groups. Patients were included in the study according to randomization order. Patients coming for surgery were randomly assigned to a pranayama group, a deep breathing group, and a control group.
This randomization technique was continued until the sample number in the research groups was reached, and the study was terminated when 22 patients were included in the pranayama group, 22 in the deep breathing group and 22 in the control group.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- pranayama-, deep breathing-, control
- Keywords
- pranayama, shoulder pain, sleep quality
- Medical subject headings
- Shoulder Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pranayama-Other
Also called PRANAYAMA
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
deep breathing-Other
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
controlOther
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
| Study group | Role | What they receive |
|---|---|---|
| pranayama- | Experimental | Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge. Receives: Other: pranayama- |
| deep breathing - | Experimental | Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge. Receives: Other: deep breathing- |
| control | Experimental | Patients will not undergo any postoperative intervention. Then, their pain will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain after laparoscopic cholecystectomy with visual analogue scale in deep breathing group, pranayama group and control groups.
On the visual analogue scale, 0 points mean no pain, and 10 points mean unbearable pain.
Measured: Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.
Secondary outcomes (1)
Evaluation of sleep of patients after laparoscopic cholecystectomy with the Richard Campbell Sleep Scale
Sleep is evaluated on a chart between 0 and 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.
Measured: The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Mar 2023
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
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 Cholecystectomy, LaparoscopicStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kurt, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495411
- Sponsor's protocol ID
- Ekurt
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurt E, Yayla A. The Effects of Pranayama and Deep Breathing Exercises on Pain and Sleep Quality After Laparoscopic Cholecystectomy. Nurs Health Sci. 2025 Mar;27(1):e70041. doi: 10.1111/nhs.70041.
PubMed 39870367
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Pranayama and Deep Breathing Exercises on Shoulder Pain and Sleep Quality After Laparoscopic Cholecystectomy"
- ClinicalTrials.gov ID
- NCT06495411
- Acronym / sponsor ID
- Ekurt
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- pranayama, shoulder pain, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Jul 2024 (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.
This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.
Detailed description
The data were collected by the researcher by face-to-face interview method at SBU Van Training and Research Hospital General Surgery Clinics. Necessary information was given to healthcare professionals in the clinics where the research would be conducted, and the lists of patients who would undergo surgery were followed. Data collection started in the preoperative period, and the data collection phase ended when the patient was discharged after the surgery.
To collect pranayama, deep breathing and control group data, the researcher identified patients who were scheduled to undergo laparoscopic cholecystectomy surgery in general surgery services on a daily basis and met the sampling criteria. In the hospital where the research was conducted, laparoscopic cholecystectomy surgeries were performed excluding emergency surgeries.
It is performed electively and patient education is provided on the day of surgery. Patients are taken into surgery according to the surgery list determined the day before.
It was determined by randomization whether the patients participating in the study would be in the control or experimental groups. Patients were included in the study according to randomization order. Patients coming for surgery were randomly assigned to a pranayama group, a deep breathing group, and a control group.
This randomization technique was continued until the sample number in the research groups was reached, and the study was terminated when 22 patients were included in the pranayama group, 22 in the deep breathing group and 22 in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pranayama- | Experimental | Other: pranayama-Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge. |
| deep breathing - | Experimental | Other: deep breathing-Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge. |
| control | Experimental | Other: controlPatients will not undergo any postoperative intervention. Then, their pain will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Shoulder pain after elective laparoscopic cholecystectomy surgery patients,
- No hearing-speech problems that would hinder communication,
- No cognitive-mental problems,
- Not having any psychiatric disease,
- No sleep disorder
Key exclusion criteria (3 listed)
- Admitted to the intensive care unit in the early postoperative period,
- Extra surgical intervention (hernia repair, etc.),
- During laparoscopic cholecystectomy, patients undergoing open cholecystectomy patients were excluded from 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 |
|---|---|---|
| pranayama-Also: PRANAYAMAPain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge. | Other | pranayama- |
| deep breathing-Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge. | Other | deep breathing - |
| controlPain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge. | Other | control |
Primary outcome
Evaluation of pain after laparoscopic cholecystectomy with visual analogue scale in deep breathing group, pranayama group and control groups.
Time frame: Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.
On the visual analogue scale, 0 points mean no pain, and 10 points mean unbearable pain.
1 secondary outcome
Evaluation of sleep of patients after laparoscopic cholecystectomy with the Richard Campbell Sleep Scale
Time frame: The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 39870367Kurt E, Yayla A. The Effects of Pranayama and Deep Breathing Exercises on Pain and Sleep Quality After Laparoscopic Cholecystectomy. Nurs Health Sci. 2025 Mar;27(1):e70041. doi: 10.1111/nhs.70041.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pranayama- and deep breathing- in people with Cholecystectomy, Laparoscopic, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of pain after laparoscopic cholecystectomy with visual analogue scale in deep breathing group, pranayama group and control groups. (time frame: Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.). 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 NCT06495411, 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 10 Jul 2024.