- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06495411
Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy
"The Effect of Pranayama and Deep Breathing Exercises on Shoulder Pain and Sleep Quality After Laparoscopic Cholecystectomy"
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25240
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
Other Names:
|
|
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.
|
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
|
|
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.
|
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ekurt
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholecystectomy, Laparoscopic
-
Wake Forest University Health SciencesAmerican College of SurgeonsCompletedCholecystectomy, Laparoscopic | Appendectomy, Laparoscopic | Cholecystectomy, RoboticUnited States
-
Clinical Research Centre, MalaysiaCompletedComplication Laparoscopic Cholecystectomy | Conversion Laparoscopic to Open CholecystectomyMalaysia
-
Intuitive SurgicalCompletedLaparoscopic Cholecystectomy | Robotic-assisted CholecystectomyUnited States
-
Assiut UniversityNot yet recruiting
-
IHU StrasbourgScialytics SASRecruitingCholecystectomy, LaparoscopicFrance
-
Assiut UniversityNot yet recruiting
-
Mohamed Bakr Mohamed AhmedNot yet recruitingLaparoscopic Cholecystectomy
-
Istanbul University - CerrahpasaActive, not recruitingCholecystectomy, LaparoscopicTurkey (Türkiye)
-
Ulas AdayCompletedLaparoscopic CholecystectomyTurkey (Türkiye)
-
Mansoura UniversityCompletedLaparoscopic CholecystectomyEgypt
Clinical Trials on pranayama-
-
Istanbul University - Cerrahpasa (IUC)Active, not recruitingObstructive Sleep Apnea SyndromeTurkey
-
Istanbul Medipol University HospitalCompletedNo ConditionTurkey (Türkiye)
-
Yeditepe UniversityRecruitingAsthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis) | The Effect of Yoga, Paranayama Yoga Practice on Respiratory DiseasesTurkey
-
National University of Natural MedicineCompletedPranayama Effect on Autonomic Nervous System | Respiration Variability Effect on Nervous SystemUnited States
-
Ondokuz Mayıs UniversityActive, not recruitingPatients Diagnosed With Fibromyalgia SyndromeTurkey (Türkiye)
-
Ondokuz Mayıs UniversityCompleted
-
Namik Kemal UniversityCompletedIndividuals Aged 60 and Over | Individuals Who Are Physically and Mentally Suitable to Practice Pranayama Breathing Technique | Individuals Without a Malignant Respiratory System Disease (Such as Bronchial and Lung Cancer) | Individuals Without a Pathological Condition Affecting Their... and other conditionsTurkey (Türkiye)
-
Bartın UnıversityCompletedAsthma in Children | Telerehabilitation | YogaTurkey
-
KTO Karatay UniversityRecruiting
-
Cairo UniversityRecruitingHypertension | Stress | Aging ProblemsEgypt