Back to resultsThe Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients
Primary Purpose
Gall Bladder Disease, Laparoscopic Cholecystectomy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mindfulness meditation and virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Gall Bladder Disease focused on measuring care, recovery, mindfulness, meditation, virtual reality
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.
Sites / Locations
- Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Experimental group (meditation)
Experimental group (virtual reality)
Control group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Meditation practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients.
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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05724277
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seçkin KARAKUŞ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Bladder Disease, Laparoscopic Cholecystectomy
Keywords
care, recovery, mindfulness, meditation, virtual reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Interventions will be applied to meditation and virtual reality groups twice before and after surgery.
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group (meditation)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental group (virtual reality)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation and virtual reality
Intervention Description
Mindfulness meditation and virtual reality
Primary Outcome Measure Information:
Title
Meditation practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
the evening before and the morning of the surgery
Title
Meditation practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients.
Description
In order to evaluate surgical fear, the Surgical Fear Scale will be applied twice, before and after the meditation practice, in the preoperative period.
Time Frame
the evening before and the morning of the surgery
Title
Meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
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
Title
Meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Title
Meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Title
Meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
on the morning of surgery and at 24 hours after surgery
Title
Meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
at 24 hours after surgery
Title
Virtual reality practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
the evening before and the morning of the surgery
Title
Virtual reality practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
the evening before and the morning of the surgery
Title
Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
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
Title
Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Title
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Title
Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Description
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.
Time Frame
on the morning of surgery and at 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seçkin KARAKUŞ, MSc
Phone
+90 (446) 226 58 62
Ext
15040
Email
seckin.karakus@erzincan.edu.tr
Facility Information:
Facility Name
Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital
City
Erzincan
ZIP/Postal Code
24030
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seçkin KARAKUŞ, MSc
Phone
05533815518
Email
seckin.karakus@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients
We'll reach out to this number within 24 hrs