NCT06511271

Brief Summary

Objective: It was conducted as a randomized controlled experimental study to determine the effect of progressive relaxation exercise applied after laparoscopic cholecystectomy on postoperative pain, nausea and vomiting. Method: The population of the study consisted of 105 patients who underwent elective planned laparoscopic cholecystectomy at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023(Study=38, Control=38). 76 patients, who constituted the sample of the study, were assigned to the study and control groups. Data were collected using the Patient Introduction Form Visual Comparison Scale and Perioperative Patient Monitoring Form. Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery. Frequency, average, Chi-Square test, Independent t-test and Repeated Measures ANOVA test were used to evaluate the data. Results: When the comparison between groups is examined; It was determined that the average pain intensity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased more than the control group and the difference between them was statistically significant (p\<0.05). When the comparison between groups is examined; It was determined that the average nausea severity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased significantly compared to the control group and the difference between them was statistically significant (p\<0.05). It was determined that there was a decrease in vomiting rates in the study group compared to the control group at the 6th and 12th hours after surgery and the difference between them was significant. Conclusion and Recommendations: It has been determined that progressive relaxation exercises reduces pain, nausea and vomiting after laparoscopic cholecystectomy. In line with the results obtained from the research, it is recommended that nurses teach progressive relaxation exercises to patients and encourage their use, as they are easy to apply to patients and are not an invasive method. Keywords: Laparoscopic cholecystectomy, nausea, nurse, pain, progressive relaxation exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

May 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

May 28, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

laparoscopic cholecystectomyPostoperative Painnauseavomiting

Outcome Measures

Primary Outcomes (1)

  • pain, nausea and vomiting 1

    The severity of pain, nausea, and vomiting was assessed by the researcher at the 2nd hour using a visual analog scale.

    at the 2nd hour after surgery

Secondary Outcomes (3)

  • pain, nausea and vomiting 2

    at the 6nd hours after surgery

  • pain, nausea and vomiting 3

    at the 12th hour after surgery

  • pain, nausea and vomiting 4

    at the 24th hour after surgery

Study Arms (2)

Group 1

NO INTERVENTION

Patients in the control group were given only the standard procedure for laparoscopic cholecystectomy during the research period. treatment and care were applied.

Group 2

EXPERIMENTAL

The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just It consists of relaxation music\[145\]. In our study, the instructions in the second part were used. - In addition to standard treatment and care for laparoscopic cholecystectomy, volunteers who accept the study Progressive relaxation exercises were applied by the researcher at the 2nd, 6th, 12th and 24th hours after surgery. When the literature review on PGE was made, it was seen that the application time and frequency of these exercises were not standard; 6th, 12th, 24th hours after surgery; It was applied on the 2nd day after surgery and the total number of sessions varied. It is seen to show. In our study, PGE was detected at the 2nd, 6t

Other: relaxation exercises

Interventions

The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just consists of relaxation music

Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \*To participate in the research willing
  • Prevents exercise creating a chronic without disease (COPD, heart failure etc.)
  • Hearing problem not found
  • At least primary school graduate the one which...
  • A psychiatric diagnosis non-major depression, anxiety disorders etc.) and anxiety or a drug for depression non-user
  • Elective laparoscopic having a cholecystectomy
  • Oriented to person, place and time the one which...
  • American Anesthesia Association(ASA) classification I, II or III the one which...

You may not qualify if:

  • Under 18 and over 70 patients over (n=2)
  • Agree to participate in the research not (n=12)
  • Patients undergoing emergency surgery
  • Prevents exercise with disease causing
  • Hearing problem found
  • Having a psychiatric diagnosis (major depression, anxiety disorders etc.) and anxiety or a depression taking medication
  • Pregnant
  • Suffering from motion sickness
  • Lack of cooperation
  • Basic during surgery in life functions developing complications
  • Open cholecystectomy (n=2)
  • American Society of Anesthesiologists (ASA) classification IV are(n=7)
  • Previous PGE exercises educated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye State Hospital

Merkez, Osmani̇ye, 80010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeNauseaVomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Didem LAFÇI, associate professor

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Lecturer

Study Record Dates

First Submitted

May 28, 2024

First Posted

July 19, 2024

Study Start

May 25, 2023

Primary Completion

August 25, 2023

Study Completion

August 25, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

no ipd

Locations