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CompletedNCT06495411Updated Jul 10, 2024

Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy

An interventional study of pranayama- and deep breathing- in Cholecystectomy, Laparoscopic, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Ataturk University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Mar 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cholecystectomy, Laparoscopic

Keywords

  • pranayama, shoulder pain, sleep quality
03

In context

Shoulder Pain

724 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 66 is close to the median of 60 across 577 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Ataturk University is the lead sponsor of 454 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    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.

    Other: pranayama-

  • Experimental
    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.

    Other: deep breathing-

  • Experimental
    control

    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.

    Other: control

Interventions

  • Otherpranayama-

    Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.

    Also known as: PRANAYAMA

  • Otherdeep breathing-

    Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.

  • Othercontrol

    Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

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.

    Time frame: The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.

07

Study locations

1 site
  • Atatürk University
    Erzurum, 25240, Turkey (Türkiye)
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Jun 2024, 15 months.

Of 327 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 15 months is above that.

Counting every sponsor, half of 336 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2024
First posted
Jul 10, 2024
StartActual
Mar 1, 2023
Primary completionActual
Jun 30, 2024
CompletionActual
Jul 1, 2024
Last update
Jul 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06495411
Lead sponsor
Ataturk University
Responsible party
Elif Kurt (graduate student, Ataturk University) — Principal investigator
First posted
Jul 10, 2024
Start date
Mar 1, 2023
Primary completion
Jun 30, 2024
Completion
Jul 1, 2024
Last update
Jul 10, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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