NCT06495411

Brief Summary

This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

June 10, 2024

Last Update Submit

July 8, 2024

Conditions

Keywords

pranayama, shoulder pain, sleep quality

Outcome Measures

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.

    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

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

Study Arms (3)

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.

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.

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.

Other: control

Interventions

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
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 -
controlOTHER

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

control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Shoulder PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

June 10, 2024

First Posted

July 10, 2024

Study Start

March 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 1, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations