Back to resultsThe Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
Primary Purpose
Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Educational and Research Hospital
Sponsored by
About this trial
This is an interventional other trial for Anxiety
Eligibility Criteria
Inclusion Criteria
- Hospitalized in the general surgery clinics,
- with histories of laparoscopic cholecystectomy,
- consenting to take part.
Exclusion Criteria:
- Have a psychiatric disorders.
Sites / Locations
- Lüleburgaz Devlet Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GROUP 1
GROUP 2
Arm Description
BREATHING EXERCISE GROUP
CONTROL GROUP
Outcomes
Primary Outcome Measures
Postoperative anxiety scores would be lower in the experimental group than in the control group.
Postoperative anxiety scores
Postoperative pain score would be lower in the experimental group than in the control group.
Postoperative pain score
Secondary Outcome Measures
Full Information
NCT ID
NCT05535491
First Posted
September 2, 2022
Last Updated
September 6, 2022
Sponsor
Kırklareli University
1. Study Identification
Unique Protocol Identification Number
NCT05535491
Brief Title
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
Official Title
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
May 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. The purpose of this study was therefore to determine the effect of postoperative breathing exercises on pain and anxiety in patients hospitalized in the general surgery clinic and who had undergone laparoscopic cholecystectomy.
Detailed Description
Introduction: Several methods are employed for overcoming pain and anxiety that are frequently experienced in the postoperative period. This study was planned to determine the effect of a breathing exercise on patient pain and anxiety after laparoscopic cholecystectomy.
Methods: The sample determined using power analysis in this randomized, controlled, semi-experimental research performed in two hospitals in the west of Turkey between January and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An information form involving descriptive characteristics, a visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive statistical methods and parametric tests were employed in the data analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP 1
Arm Type
Experimental
Arm Description
BREATHING EXERCISE GROUP
Arm Title
GROUP 2
Arm Type
No Intervention
Arm Description
CONTROL GROUP
Intervention Type
Other
Intervention Name(s)
Educational and Research Hospital
Intervention Description
breathing exercise
Primary Outcome Measure Information:
Title
Postoperative anxiety scores would be lower in the experimental group than in the control group.
Description
Postoperative anxiety scores
Time Frame
six months
Title
Postoperative pain score would be lower in the experimental group than in the control group.
Description
Postoperative pain score
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Hospitalized in the general surgery clinics,
with histories of laparoscopic cholecystectomy,
consenting to take part.
Exclusion Criteria:
- Have a psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aylin AYDIN SAYILAN, PhD
Organizational Affiliation
Kırklareli University
Official's Role
Study Chair
Facility Information:
Facility Name
Lüleburgaz Devlet Hastanesi
City
Kırklareli
State/Province
Merkez
ZIP/Postal Code
39020
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30470466
Citation
Koras K, Karabulut N. The Effect of Foot Massage on Postoperative Pain and Anxiety Levels in Laparoscopic Cholecystectomy Surgery: A Randomized Controlled Experimental Study. J Perianesth Nurs. 2019 Jun;34(3):551-558. doi: 10.1016/j.jopan.2018.07.006. Epub 2018 Nov 20.
Results Reference
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PubMed Identifier
30921794
Citation
Saritas S, Genc H, Okutan S, Inci R, Ozdemir A, Kizilkaya G. The Effect of Comedy Films on Postoperative Pain and Anxiety in Surgical Oncology Patients. Complement Med Res. 2019;26(4):231-239. doi: 10.1159/000497234. Epub 2019 Mar 27.
Results Reference
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PubMed Identifier
31517775
Citation
Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
Results Reference
background
PubMed Identifier
33050409
Citation
Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526.
Results Reference
background
PubMed Identifier
31555379
Citation
Ju W, Ren L, Chen J, Du Y. Efficacy of relaxation therapy as an effective nursing intervention for post-operative pain relief in patients undergoing abdominal surgery: A systematic review and meta-analysis. Exp Ther Med. 2019 Oct;18(4):2909-2916. doi: 10.3892/etm.2019.7915. Epub 2019 Aug 19.
Results Reference
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Learn more about this trial
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
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