Clinical trial NCT04710121: The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level
Official title: The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
virtual reality glasses
pain
anxiety
vital signs
nursing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled study to determine the effects of virtual reality glasses used during the colonoscopy on vital signs, pain, and anxiety levels.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. After the approval of the ethics committee and institutional permission, 60 patients who applied to the endoscopy unit for colonoscopy procedure between 1 October 2020 and 1 October 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0,665 (effect size), α = 0.05 (margin of error), 1-β = 0.80 (Power) and by using the G-Power package program with the specified criteria. It was decided to recruit 58 people (29 people per group). The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the colonoscopy, the patient will be visited and information will be given about the purpose, content, and intervention to be applied. After obtaining verbal and written consent from the patients who accepted to participate in the study, the "Individual Characteristics Form" will be filled. Then, before the colonoscopy procedure, the anxiety states of the patients in the experimental and control groups will be asked with the "State and Trait Anxiety Inventory", their pain status with the Analog Scale (VAS), and their first life findings will be measured and the first measurement values will be recorded in the "Vital Signs Follow-up Form".

The patients in the experimental group will be informed about the virtual glasses before the colonoscopy procedure and the virtual reality glasses will be placed on the patient's head during the procedure. Then, during the colonoscopy procedure, the duration of the colonoscopy will vary between 3-10 minutes, and during the colonoscopy period, videos with music background, parks, nature and seaside walks, underwater, etc., will be watched by the patient and the "Vital Signs Tracking Form" The second measurement values will be saved by making measurement to.

Immediately after the colonoscopy procedure is finished, "Visual Analogue Scale (VAS)", "Life Findings Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. The standard application will be applied to the patients in the control group during the colonoscopy procedure and the second measurement values will be recorded by measuring the "Vital Signs Follow-up Form".Immediately after the colonoscopy procedure is completed, the third measurement value will be recorded by measuring the "Visual Analogue Scale (VAS)" and "Vital Signs Follow-up Form". "State Anxiety Inventory" will be read and the answers recorded.

Detailed description: The universe of the research; patients who are between October 1, 2020, and October 1, 2021, in the endoscopy unit for colonoscopy procedure where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's endoscopy unit between 1 October 2020 - 1 October 2021. The independent variable of the study is virtual reality glasses. The dependent variables of the study are anxiety states, pain intensity, and vital signs score average. In the research, "Individual Characteristics Form", "State and Trait Anxiety Inventory", the Analog Scale (VAS), and "Vital Signs Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Having the ability to read and write in Turkish,
* According to the American Anesthesiologists Association (ASA) classification; ASA score of I or II,
* The patient expresses that he / she has no mental disorder,
* Stating that the patient is not using any anti-anxiety (anxiolytic) medication,
* Migraine, vertigo, active nausea, vomiting, headache... etc. absence of a situation,
* No vision, hearing or perception problems,
* No previous abdominal surgery (no large intestine surgery, lower abdominal surgery),
* Being conscious, oriented, cooperative and open to communication.

Exclusion Criteria:

* Malignancy (GIS and all malignancies),
* Not enough bowel cleansing,
* There is no fasting period of at least 8 hours,
* Possible pregnancy or pregnancy.

Primary outcomes:
measure: Pre-colonoscopy state of anxiety
timeFrame: Reported state of anxiety in the first 10 minutes before the colonoscopy procedure
measure: Pre-colonoscopy pain severity
timeFrame: Reported pain severity in the first 5 minutes before the colonoscopy procedure
measure: Heart rate before the colonoscopy procedure
timeFrame: Immediately before the colonoscopy procedure
measure: Blood pressure before the colonoscopy procedure
timeFrame: Immediately before the colonoscopy procedure
measure: Respiration rate before the colonoscopy procedure
timeFrame: Immediately before the colonoscopy procedure
measure: Oxygen saturation (SpO2) before the colonoscopy procedure
timeFrame: Immediately before the colonoscopy procedure
measure: Heart rate during the colonoscopy procedure
timeFrame: During the colonoscopy procedure
measure: Blood pressure during the colonoscopy procedure
timeFrame: During the colonoscopy procedure
measure: Respiration rate during the colonoscopy procedure
timeFrame: During the colonoscopy procedure
measure: Oxygen saturation (SpO2) during the colonoscopy procedure
timeFrame: During the colonoscopy procedure
measure: Heart rate after the colonoscopy procedure
timeFrame: Reported heart rate/per minute in the first 5 minutes after the colonoscopy procedure
measure: Respiration rate after the colonoscopy procedure
timeFrame: Reported respiration rate/per minute in the first 5 minutes after the colonoscopy procedure
measure: Blood pressure after the colonoscopy procedure
timeFrame: Reported blood pressure in the first 5 minutes after the colonoscopy procedure
measure: Oxygen saturation (SpO2) after the colonoscopy procedure
timeFrame: in the first 5 minutes after the colonoscopy procedure
measure: Post-colonoscopy pain
timeFrame: Reported pain severity in the first 5 minutes after the colonoscopy procedure
measure: Pre-colonoscopy state of anxiety
timeFrame: Reported state of anxiety in the first 10 minutes after the colonoscopy procedure
Secondary outcomes:
measure: Satisfaction status with virtual reality glasses application
timeFrame: Satisfaction is reported within the first 15 minutes after the colonoscopy procedure.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayfer ÖZBAŞ, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Esra KILINÇ AKMAN, MSC
role: STUDY_CHAIR
References: