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

NCT05724277 | Completed DMC

• 1 other identifier: SeckinTez
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gall Bladder Disease; Laparoscopic Cholecystectomy

Keywords

recovery; mindfulness; meditation; virtual reality; nursing care

Outcome Measures

Primary Outcomes (12)

• Mindfulness meditation practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.

  In order to evaluate surgical fear, the Surgical Fear Scale will be applied twice, before and after the mindfulness meditation practice, in the preoperative period.

  the evening before and the morning of the surgery

• Mindfulness meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.

  In order to evaluate sleep quality, the Richard Campbell Sleep Questionnaire will be applied in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery.

  in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery

• Mindfulness meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.

  In order to evaluate nausea, the Numerical Rating Scale will be applied five times in the postoperative period at the 0th, 2nd, 6th, 12th, and 24th hours after the surgery.

  at postoperative 0th, 2nd, 6th, 12th and 24th hours

• Mindfulness meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.

  In order to evaluate the pain, the Numerical Rating Scale will be applied five times in the postoperative period at the 0th, 2nd, 6th, 12th, and 24th hours after the surgery.

  at postoperative 0th, 2nd, 6th, 12th and 24th hours

• Mindfulness meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.

  In order to evaluate the recovery quality, the Quality of Recovery-15T Questionnaire will be applied in the preoperative period and in the postoperative period.

  in the preoperative period, evening before surgery and in the postoperative period, morning after surgery

• Mindfulness meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.

  In order to evaluate patient satisfaction, Watson Caritas Patient Score will be applied once in the postoperative period.

  at 24 hours after surgery

• Virtual reality practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.

  In order to evaluate surgical fear, the Surgical Fear Scale will be applied twice, before and after the virtual reality practice, in the preoperative period.

  the evening before and the morning of the surgery

• Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.

  In order to evaluate sleep quality, the Richard Campbell Sleep Questionnaire will be applied in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery.

  in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery

• Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.

  In order to evaluate nausea, the Numerical Rating Scale will be applied five times in the postoperative period at the 0th, 2nd, 6th, 12th, and 24th hours after the surgery.

  at postoperative 0th, 2nd, 6th, 12th and 24th hours

• Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.

  In order to evaluate pain, the Numerical Rating Scale will be applied five times in the postoperative period at the 0th, 2nd, 6th, 12th, and 24th hours after the surgery.

  at postoperative 0th, 2nd, 6th, 12th and 24th hours

• Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.

  In order to evaluate the recovery quality, the Quality of Recovery-15T Questionnaire will be applied in the preoperative period and in the postoperative period.

  in the preoperative period, evening before surgery and in the postoperative period, morning after surgery

• Virtual reality practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.

  In order to evaluate patient satisfaction, Watson Caritas Patient Score will be applied once in the postoperative period.

  at 24 hours after surgery

Secondary Outcomes (2)

• Mindfulness meditation and virtual reality applications have positive effects on vital signs.

  twice in the preoperative period and five times in the postoperative period

• Mindfulness meditation and virtual reality applications have positive effects on blood glucose regulation.

  in the preoperative period, morning before surgery and in the postoperative period, morning after surgery

Study Arms (3)

Mindfulness Meditation Group

EXPERIMENTAL

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.

Behavioral: Mindfulness Meditation

Virtual Reality Group

EXPERIMENTAL

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.

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

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.

Interventions

Mindfulness Meditation BEHAVIORAL

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

Mindfulness Meditation Group

Virtual Reality BEHAVIORAL

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

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital

Erzincan, Erzincan, 24030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ataturk University

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

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: December 30, 2022
• Primary Completion: June 24, 2024
• Study Completion: August 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)