Clinical trial NCT05724277: The Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients
Official title: Comparison of the Effects of Theory of Human Caring Based Short-Term Mindfulness Meditation and Virtual Reality on Patients Scheduled for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Bladder Disease
Laparoscopic Cholecystectomy
Keywords: recovery
mindfulness
meditation
virtual reality
nursing care
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mindfulness meditation practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.
timeFrame: the evening before and the morning of the surgery
measure: Mindfulness meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
timeFrame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery
measure: Mindfulness meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
timeFrame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
measure: Mindfulness meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.
timeFrame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
measure: Mindfulness meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
timeFrame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
measure: Mindfulness meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.
timeFrame: at 24 hours after surgery
measure: Virtual reality practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.
timeFrame: the evening before and the morning of the surgery
measure: Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
timeFrame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery
measure: Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
timeFrame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
measure: Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.
timeFrame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
measure: Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
timeFrame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
measure: Virtual reality practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: Mindfulness meditation and virtual reality applications have positive effects on vital signs.
timeFrame: twice in the preoperative period and five times in the postoperative period
measure: Mindfulness meditation and virtual reality applications have positive effects on blood glucose regulation.
timeFrame: in the preoperative period, morning before surgery and in the postoperative period, morning after surgery
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital
Study officials:
References: