NCT05535491

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 2, 2022

Last Update Submit

September 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative anxiety scores would be lower in the experimental group than in the control group.

    Postoperative anxiety scores

    six months

  • Postoperative pain score would be lower in the experimental group than in the control group.

    Postoperative pain score

    six months

Study Arms (2)

GROUP 1

EXPERIMENTAL

BREATHING EXERCISE GROUP

Other: Educational and Research Hospital

GROUP 2

NO INTERVENTION

CONTROL GROUP

Interventions

breathing exercise

GROUP 1

Eligibility Criteria

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

You may qualify if:

  • Hospitalized in the general surgery clinics,
  • with histories of laparoscopic cholecystectomy,
  • consenting to take part.

You may not qualify if:

  • \- Have a psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lüleburgaz Devlet Hastanesi

Kırklareli, Merkez, 39020, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 30470466BACKGROUND
  • 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.

    PMID: 30921794BACKGROUND
  • 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.

    PMID: 31517775BACKGROUND
  • 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.

    PMID: 33050409BACKGROUND
  • 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.

    PMID: 31555379BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aylin AYDIN SAYILAN, PhD

    Kırklareli University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 10, 2022

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

May 25, 2020

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations