An interventional study of Mindfulness Meditation and Virtual Reality in Gall Bladder Disease and Laparoscopic Cholecystectomy, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
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.
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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 160 is above the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mindfulness meditation will be applied to the patients in the Mindfulness Meditation Group for 15 minutes in the preoperative period, in both evening and morning.
Behavioral: Mindfulness Meditation
Virtual reality will be experienced to the patients in the Virtual Reality Group for 15 minutes in the preoperative period, in both evening and morning.
Behavioral: Virtual Reality
The patients in the Control Group will not undergo any intervention in the preoperative period and will receive the routine nursing care of the clinic.
A 15-minute mindfulness meditation will be conducted by the meditation instructor researcher.
A 10-minute virtual reality experience will be provided by using virtual reality glasses.
Mindfulness meditation practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients.
In order to evaluate surgical fear, the Surgical Fear Scale will be applied twice, before and after the mindfulness meditation practice, in the preoperative period.
Time frame: the evening before and the morning of the surgery
Mindfulness meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
In 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.
Time frame: 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.
In 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.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
Mindfulness 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 five times in the postoperative period at the 0th, 2nd, 6th, 12th, and 24th hours after the surgery.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
Mindfulness 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 Questionnaire will be applied in the preoperative period and in the postoperative period.
Time frame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
Mindfulness 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 in the postoperative period.
Time frame: at 24 hours after surgery
Virtual reality practice provides a positive change in surgical fear 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.
Time frame: the evening before and the morning of the surgery
Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
In 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.
Time frame: 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.
In 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.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.
In 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.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
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 Questionnaire will be applied in the preoperative period and in the postoperative period.
Time frame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
Virtual reality 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 in the postoperative period.
Time frame: at 24 hours after surgery
Mindfulness meditation and virtual reality applications have positive effects on vital signs.
Time frame: twice in the preoperative period and five times in the postoperative period
Mindfulness meditation and virtual reality applications have positive effects on blood glucose regulation.
Time frame: in the preoperative period, morning before surgery and in the postoperative period, morning after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Jun 2024, 17 months.
Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 17 months is above that.
Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.