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NCT Number: NCT05724277

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

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.

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Key information

Conditions

Gall Bladder Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Laparoscopic Cholecystectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital

Erzincan, 24030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Meditation

Behavioral

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

Virtual reality

Behavioral

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

Primary outcomes

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

    Time frame: the evening before and the morning of the surgery

    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.

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

    Time frame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: at 24 hours after surgery

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

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

    Time frame: the evening before and the morning of the surgery

    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.

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

    Time frame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: at 24 hours after surgery

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

Secondary outcomes

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

    Time frame: twice in the preoperative period and five times in the postoperative period

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

    Time frame: in the preoperative period, morning before surgery and in the postoperative period, morning after surgery

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Comparison of the Effects of Theory of Human Caring Based Short-Term Mindfulness Meditation and Virtual Reality on Patients Scheduled for Laparoscopic Cholecystectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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