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

Laparoscopic Cholecystectomy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724277
• Other study ID #: SeckinTez
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Ataturk University
• Contact: Seçkin KARAKUS, MSc
• Phone: +90 (446) 226 58 62
• Email: seckin.karakus[@]erzincan.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gall Bladder Disease
• Gallbladder Diseases
• Laparoscopic Cholecystectomy
• Urinary Bladder Diseases

Intervention

Behavioral:
• Mindfulness meditation and virtual reality
Mindfulness meditation and virtual reality

Locations

Country	Name	City	State
Turkey	Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital	Erzincan

Sponsors (1)

Lead Sponsor	Collaborator
Seçkin KARAKUS

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the evening before and the morning of the surgery
Primary	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.	the evening before and the morning of the surgery
Primary	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.	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
Primary	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.	at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Primary	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.	at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Primary	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.	on the morning of surgery and at 24 hours after surgery
Primary	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.	at 24 hours after surgery
Primary	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.	the evening before and the morning of the surgery
Primary	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.	the evening before and the morning of the surgery
Primary	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.	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
Primary	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.	at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Primary	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.	at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Primary	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.	on the morning of surgery and at 24 hours after surgery