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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05724277
Enrollment
160
Registered
2023-02-13
Start date
2022-12-30
Completion date
2024-08-02
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Bladder Disease, Laparoscopic Cholecystectomy

Keywords

recovery, mindfulness, meditation, virtual reality, nursing 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.

Interventions

BEHAVIORALMindfulness Meditation

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

BEHAVIORALVirtual Reality

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

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Virtual reality practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.at 24 hours after surgeryIn order to evaluate patient satisfaction, Watson Caritas Patient Score will be applied once in the postoperative period.
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.at postoperative 0th, 2nd, 6th, 12th and 24th hoursIn 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.
Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.in the preoperative period, evening before surgery and in the postoperative period, morning after surgeryIn order to evaluate the recovery quality, the Quality of Recovery-15T Questionnaire will be applied in the preoperative period and in the postoperative period.
Mindfulness meditation practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.the evening before and the morning of the surgeryIn order to evaluate surgical fear, the Surgical Fear Scale will be applied twice, before and after the mindfulness meditation practice, in the preoperative period.
Mindfulness meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgeryIn 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.
Mindfulness meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.at postoperative 0th, 2nd, 6th, 12th and 24th hoursIn 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.
Mindfulness meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.at postoperative 0th, 2nd, 6th, 12th and 24th hoursIn 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.
Mindfulness meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.in the preoperative period, evening before surgery and in the postoperative period, morning after surgeryIn order to evaluate the recovery quality, the Quality of Recovery-15T Questionnaire will be applied in the preoperative period and in the postoperative period.
Mindfulness meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.at 24 hours after surgeryIn order to evaluate patient satisfaction, Watson Caritas Patient Score will be applied once in the postoperative period.
Virtual reality practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.the evening before and the morning of the surgeryIn 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 morning of the surgery and in the postoperative period, in the morning after the surgeryIn 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.
Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.at postoperative 0th, 2nd, 6th, 12th and 24th hoursIn 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.

Secondary

MeasureTime frame
Mindfulness meditation and virtual reality applications have positive effects on blood glucose regulation.in the preoperative period, morning before surgery and in the postoperative period, morning after surgery
Mindfulness meditation and virtual reality applications have positive effects on vital signs.twice in the preoperative period and five times in the postoperative period

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026