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

Sponsor

Seçkin KARAKUŞ (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05724277

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, it is aimed to compare the effects of short-term mindfulness meditation based on Human Caring Theory and virtual reality on patients scheduled for laparoscopic cholecystectomy.

Condition or Disease	Intervention/Treatment	Phase
Gall Bladder Disease Laparoscopic Cholecystectomy	Behavioral: Mindfulness meditation and virtual reality	N/A

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. In this study, it is aimed to compare the effects of short-term mindfulness meditation based on Human Caring Theory and virtual reality on patients scheduled for laparoscopic cholecystectomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Interventions will be applied to meditation and virtual reality groups twice before and after surgery.Interventions will be applied to meditation and virtual reality groups twice before and after surgery.

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group (meditation) Meditation will be applied to the patients in the meditation group for 10 minutes in the evening and morning of the operation in the preoperative period, and at the 2nd and 12th hours in the postoperative period. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, Recovery Quality-15 Scale and Watson Caritas Patient Score. In addition, data will be collected using the Patient Follow-up Form (Experimental Group) both before and after the interventions.	Behavioral: Mindfulness meditation and virtual reality Mindfulness meditation and virtual reality
Experimental: Experimental group (virtual reality) Virtual reality will be applied to the patients in the virtual reality group for 10 minutes in the evening and morning of the operation in the preoperative period, and at the 2nd and 12th hours in the postoperative period. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, and Recovery Quality-15 Scale. In addition, data will be collected using the Patient Follow-up Form (Experimental Group) both before and after the interventions.	Behavioral: Mindfulness meditation and virtual reality Mindfulness meditation and virtual reality
No Intervention: Control group The patients in the control group will not undergo any intervention in the pre- and postoperative period and will receive the routine nursing care of the clinic. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, and Recovery Quality-15 Scale. In addition, data will be collected by using the Patient Follow-up Form (Control Group) in the determined periods after the surgery in parallel with the experimental groups.

Arm

Intervention/Treatment

Experimental: Experimental group (meditation)

Meditation will be applied to the patients in the meditation group for 10 minutes in the evening and morning of the operation in the preoperative period, and at the 2nd and 12th hours in the postoperative period. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, Recovery Quality-15 Scale and Watson Caritas Patient Score. In addition, data will be collected using the Patient Follow-up Form (Experimental Group) both before and after the interventions.

Behavioral: Mindfulness meditation and virtual reality

Mindfulness meditation and virtual reality

Experimental: Experimental group (virtual reality)

Virtual reality will be applied to the patients in the virtual reality group for 10 minutes in the evening and morning of the operation in the preoperative period, and at the 2nd and 12th hours in the postoperative period. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, and Recovery Quality-15 Scale. In addition, data will be collected using the Patient Follow-up Form (Experimental Group) both before and after the interventions.

Behavioral: Mindfulness meditation and virtual reality

Mindfulness meditation and virtual reality

No Intervention: Control group

The patients in the control group will not undergo any intervention in the pre- and postoperative period and will receive the routine nursing care of the clinic. In the preoperative period, the patients were evaluated by using the Descriptive Characteristics Form, the Surgery-Specific Anxiety Scale, the Surgical Fear Scale, the Richard Campbell Sleep Scale, and the Recovery Quality-15 Scale and in the postoperative period, the patients were evaluated by using the Richard Campbell Sleep Scale, Nausea Numerical Scale, Numerical Rating Scale, and Recovery Quality-15 Scale. In addition, data will be collected by using the Patient Follow-up Form (Control Group) in the determined periods after the surgery in parallel with the experimental groups.

Outcome Measures

Primary Outcome Measures

Meditation practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients. [the evening before and the morning of the surgery]
In order to evaluate the anxiety specific to the surgery, the Surgery-Specific Anxiety Scale will be applied twice, before the meditation practice and after the meditation practice, in the preoperative period.
Meditation practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients. [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 meditation practice, in the preoperative period.
Meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients. [in the preoperative period, in the evening before the operation and on the morning of the operation, and at the 24th hour in the postoperative period]
In order to evaluate sleep quality, the Richard Campbell Sleep Scale will be applied twice in the preoperative period, before and after the meditation practice, and once at the 24th hour after the meditation practice in the postoperative period.
Meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients. [at 0th, 2nd, 6th, 12th and 24th hours postoperatively]
In order to evaluate nausea, the Nausea Numerical Scale will be applied three times, at the 0th, 2nd and 12th hours before the meditation practice, and twice, at the 6th and 24th hours after the meditation practice, in the postoperative period.
Meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients. [at 0th, 2nd, 6th, 12th and 24th hours postoperatively]
In order to evaluate the pain, the Numerical Rating Scale will be applied three times, at the 0th, 2nd and 12th hours before the meditation practice, and twice, at the 6th and 24th hours after the meditation practice, in the postoperative period.
Meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients. [on the morning of surgery and at 24 hours after surgery]
In order to evaluate the recovery quality, the Quality of Recovery-15T Scale will be applied once after the meditation practice in the preoperative period and once at the 24th hour after the meditation practice in the postoperative period.
Meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients. [at 24 hours after surgery]
In order to evaluate patient satisfaction, Watson Caritas Patient Score will be applied once at the 24th hour after the meditation practice in the postoperative period.
Virtual reality practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients. [the evening before and the morning of the surgery]
In order to evaluate the anxiety specific to the surgery, the Surgery-Specific Anxiety Scale will be applied twice, before the virtual reality practice and after the virtual reality practice, in the preoperative period.
Virtual reality practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients. [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.
Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients. [in the preoperative period, in the evening before the operation and on the morning of the operation, and at the 24th hour in the postoperative period]
In order to evaluate sleep quality, the Richard Campbell Sleep Scale will be applied twice in the preoperative period, before and after the virtual reality practice, and once at the 24th hour after the virtual reality practice in the postoperative period.
Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients. [at 0th, 2nd, 6th, 12th and 24th hours postoperatively]
In order to evaluate nausea, the Nausea Numerical Scale will be applied three times, at the 0th, 2nd and 12th hours before the virtual reality practice, and twice, at the 6th and 24th hours after the virtual reality practice, in the postoperative period.
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients. [at 0th, 2nd, 6th, 12th and 24th hours postoperatively]
In order to evaluate the pain, the Numerical Rating Scale will be applied three times, at the 0th, 2nd and 12th hours before the virtual reality practice, and twice, at the 6th and 24th hours after the virtual reality practice, in the postoperative period.
Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients. [on the morning of surgery and at 24 hours after surgery]
In order to evaluate the recovery quality, the Quality of Recovery-15T Scale will be applied once after the virtual reality practice in the preoperative period and once at the 24th hour after the virtual reality practice in the postoperative period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.