The Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients

NCT ID: NCT05724277

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2024-08-02

Brief Summary

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This study aims to compare the effects of the Theory of Human Caring based short-term mindfulness meditation and virtual reality on patients scheduled for laparoscopic cholecystectomy.

Detailed Description

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Anxiety, fear and sleep disorders are frequently encountered conditions in preoperative patient evaluation. Common postoperative problems include pain, sleep disturbances, nausea and vomiting. When these problems are not dealt with effectively, patient comfort and satisfaction are adversely affected, recovery time after surgery and total hospital stay are prolonged, and the time allocated to nursing care increases. Today, it has gained great importance to try to manage these problems with pharmacological and non-pharmacological evidence-based approaches. In particular, nurses need to identify possible problems in both preoperative patient evaluation and postoperative patient follow-up and produce solutions for them. Although it is stated in studies that using easy, effective and safe non-invasive methods such as meditation and virtual reality can reduce the possibility of complications, increase the comfort level of patients, improve the quality of post-surgical recovery, and thus make the surgical process successful, there is no evidence to defend its effectiveness more clearly. more based studies are needed.

Conditions

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Gall Bladder Disease Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two different interventions (mindfulness meditation and virtual reality) will be applied to two different experimental groups before surgery. The control group has no intervention.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mindfulness Meditation Group

Mindfulness meditation will be applied to the patients in the Mindfulness Meditation Group for 15 minutes in the preoperative period, in both evening and morning.

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

A 15-minute mindfulness meditation will be conducted by the meditation instructor researcher.

Virtual Reality Group

Virtual reality will be experienced to the patients in the Virtual Reality Group for 15 minutes in the preoperative period, in both evening and morning.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

A 10-minute virtual reality experience will be provided by using virtual reality glasses.

Control Group

The patients in the Control Group will not undergo any intervention in the preoperative period and will receive the routine nursing care of the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness Meditation

A 15-minute mindfulness meditation will be conducted by the meditation instructor researcher.

Intervention Type BEHAVIORAL

Virtual Reality

A 10-minute virtual reality experience will be provided by using virtual reality glasses.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years old and over,
* To undergo laparoscopic cholecystectomy operation,
* No orientation problem,
* Volunteering to participate in the study.

Exclusion Criteria

* Conversion from laparoscopic approach to open cholecystectomy in the operating room,
* Complications that may affect participation in the study,
* Taking the patient to the intensive care unit after surgery,
* Refusal to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Seçkin KARAKUŞ

Ataturk University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital

Erzincan, Erzincan, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SeckinTez

Identifier Type: -

Identifier Source: org_study_id

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