CClinicalTrials.gg
CompletedNCT06511271OSHUpdated Jul 19, 2024

Osmaniye State Hospital"

An interventional study of relaxation exercises in Laparoscopic Cholecystectomy, sponsored by Osmaniye Korkut Ata University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Osmaniye Korkut Ata University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

Data were collected at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023.

Among 76 patients who were hospitalized for laparoscopic cholecystectomy and volunteered to participate in the study (Study group = 38, Control group = 38) was taken. Before starting the application, ;Informed Voluntary ; was obtained from the patients.

Verbal and written permissions were obtained by reading the ; (Annex-I). Working group - Before the patient undergoes surgery, the Patient Information Form (Annex-II) information is obtained from the patient file and asked to the patient.

has been filled.

  • The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
  • 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.

  • 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, 6th, 12th and 24th hours after surgery.

has been implemented.Control group patients were informed about the research and received Informed Voluntary Consent Form (ANNEX-I) verbal and written permissions were obtained. - Before the surgery, the Patient Introduction Form (Annex-II) was checked both from the file and received verbal confirmation from the patient.

was filled in.

  • The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
  • Patients in the control group were given the standard procedure for laparoscopic cholecystectomy only during the research period.

treatment and care were applied.

  • No postoperative intervention was performed on the control group, and the researcher did not perform surgery after surgery.

Visual Comparison Scale (ANNEX-III) form for the severity of pain, nausea and vomiting at the 2nd, 6th, 12th and 24th hours The patient is asked to mark it with a pen or verbally indicate the severity between 1 and 10 on the form.

marking has been made.

  • After the postoperative pain, nausea and vomiting status is determined on the Visual Comparison Scale, perioperative Patient Follow-up Form (ANNEX-IV) has been filled out.
  • Data collection process of the research in order to eliminate ethical problems that may occur in the control group After completion, these patients were trained in progressive relaxation exercises.
02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • laparoscopic cholecystectomy
  • Postoperative Pain
  • nausea
  • vomiting
03

In context

Lead sponsor

Osmaniye Korkut Ata University is the lead sponsor of 35 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • *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...

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • No intervention
    Group 1

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

  • Experimental
    Group 2

    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

  • Otherrelaxation exercises

    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

06

What researchers measure

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.

    Time frame: at the 2nd hour after surgery

Secondary outcomes

  1. pain, nausea and vomiting 2

    he severity of pain, nausea, and vomiting was assessed by the researcher at the 6th hour using a visual analog scale. vomiting at the 6th hours after surgery.

    Time frame: at the 6nd hours after surgery

  2. pain, nausea and vomiting 3

    The severity of pain, nausea, and vomiting was assessed by the researcher at the 12 thhour using a visual analog scale.

    Time frame: at the 12th hour after surgery

  3. pain, nausea and vomiting 4

    The severity of pain, nausea, and vomiting was assessed by the researcher at the 24th hour using a visual analog scale.

    Time frame: at the 24th hour after surgery

07

Study locations

1 site
  • Osmaniye State Hospital
    Merkez, Osmani̇ye 80010, Turkey
08

References and documents

Individual participant data

Plan to share: No — no ipd

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511271
Lead sponsor
Osmaniye Korkut Ata University
Responsible party
Songul Gungor (Phd Lecturer, Osmaniye Korkut Ata University) — Principal investigator
First posted
Jul 19, 2024
Start date
May 25, 2023
Primary completion
Aug 25, 2023
Completion
Aug 25, 2023
Last update
Jul 19, 2024

Study contacts

Didem LAFÇI, associate professor
study director · Mersin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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