Gall Bladder DiseaseNCT05724277
The Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients
A study testing Mindfulness Meditation and Virtual Reality in people with Gall Bladder Disease and Laparoscopic Cholecystectomy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gall Bladder Disease, Laparoscopic Cholecystectomy
- What is being tested?
- Mindfulness Meditation and Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over,
- To undergo laparoscopic cholecystectomy operation,
- No orientation problem,
- Volunteering to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim University - Mengücek Gazi Education and Research Hospital
Erzincan, Erzincan, 24030
About this study
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
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.
Read the 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.
- Conditions
- Gall Bladder Disease, Laparoscopic Cholecystectomy
- Being tested
- Mindfulness Meditation, Virtual Reality
- Keywords
- recovery, mindfulness, meditation, virtual reality, nursing care
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
A 15-minute mindfulness meditation will be conducted by the meditation instructor researcher.
Virtual RealityBehavioural
A 10-minute virtual reality experience will be provided by using virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Group | Experimental | 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. Receives: Behavioral: Mindfulness Meditation |
| Virtual Reality Group | Experimental | 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. Receives: Behavioral: Virtual Reality |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 24 hours after surgery
Secondary outcomes (2)
Mindfulness meditation and virtual reality applications have positive effects on vital signs.
Measured: 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.
Measured: in the preoperative period, morning before surgery and in the postoperative period, morning after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start30 Dec 2022
- Primary completion24 Jun 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder DiseaseStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçkin KARAKUŞ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724277
- Sponsor's protocol ID
- SeckinTez
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05724277
- Acronym / sponsor ID
- SeckinTez
- Conditions
- Gall Bladder Disease, Laparoscopic Cholecystectomy
- Keywords
- recovery, mindfulness, meditation, virtual reality, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Group | Experimental | Behavioral: Mindfulness MeditationMindfulness meditation will be applied to the patients in the Mindfulness Meditation Group for 15 minutes in the preoperative period, in both evening and morning. |
| Virtual Reality Group | Experimental | Behavioral: Virtual RealityVirtual reality will be experienced to the patients in the Virtual Reality Group for 15 minutes in the preoperative period, in both evening and morning. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and over,
- To undergo laparoscopic cholecystectomy operation,
- No orientation problem,
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationA 15-minute mindfulness meditation will be conducted by the meditation instructor researcher. | Behavioural | Mindfulness Meditation Group |
| Virtual RealityA 10-minute virtual reality experience will be provided by using virtual reality glasses. | Behavioural | Virtual Reality Group |
Primary outcome
Mindfulness meditation practice provides a positive change in surgical fear 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 mindfulness meditation practice, in the preoperative period.
Mindfulness meditation practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
Time frame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery
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.
Mindfulness meditation practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
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.
Mindfulness meditation practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
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.
Mindfulness meditation practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Time frame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
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.
Mindfulness 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 in the postoperative period.
Virtual reality practice provides a positive change in surgical fear 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.
Virtual reality practice provides a positive change in sleep quality in laparoscopic cholecystectomy patients.
Time frame: in the preoperative period, in the morning of the surgery and in the postoperative period, in the morning after the surgery
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.
Virtual reality practice provides a positive change in nausea in laparoscopic cholecystectomy patients.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
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.
Virtual reality practice provides a positive change in pain in laparoscopic cholecystectomy patients.
Time frame: at postoperative 0th, 2nd, 6th, 12th and 24th hours
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.
Virtual reality practice provides a positive change on the quality of recovery in laparoscopic cholecystectomy patients.
Time frame: in the preoperative period, evening before surgery and in the postoperative period, morning after surgery
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.
Virtual reality 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 in the postoperative period.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Gall Bladder Disease
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Virtual Reality in people with Gall Bladder Disease and Laparoscopic Cholecystectomy, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness meditation practice provides a positive change in surgical fear in laparoscopic cholecystectomy patients. (time frame: the evening before and the morning of the surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.