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

February 2, 2023 updated by: Seçkin KARAKUŞ

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Erzincan, Turkey, 24030
        • Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Meditation practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients.
Time Frame: 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.
the evening before and the morning of the surgery
Meditation practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients.
Time Frame: 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.
the evening before and the morning of the surgery
Meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
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
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
Meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Time Frame: 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.
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Time Frame: 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.
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Time Frame: 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.
on the morning of surgery and at 24 hours after surgery
Meditation practice provides a positive change on patient satisfaction in laparoscopic cholecystectomy patients.
Time Frame: 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.
at 24 hours after surgery
Virtual reality practice provides a positive change on the anxiety specific to surgery in laparoscopic cholecystectomy patients.
Time Frame: 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.
the evening before and the morning of the surgery
Virtual reality practice provides a positive change in fear of surgery in laparoscopic cholecystectomy patients.
Time Frame: 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.
the evening before and the morning of the surgery
Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
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
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
Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Time Frame: 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.
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Time Frame: 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.
at 0th, 2nd, 6th, 12th and 24th hours postoperatively
Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Time Frame: 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.
on the morning of surgery and at 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seçkin KARAKUŞ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SeckinTez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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