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NCT Number: NCT06495411

Pranayama and Deep Breathing Exercises 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.

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Key information

Conditions

Cholecystectomy, Laparoscopic Arthralgia Dyssomnias Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

pranayama-

Other

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

Other names: PRANAYAMA

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.

Control

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

"The Effect of Pranayama and Deep Breathing Exercises on Shoulder Pain and Sleep Quality After Laparoscopic Cholecystectomy"

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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