The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level

NCT04710121 | Unknown DMC

• 1 other identifier: 2020/42-12
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Keywords

colonoscopy; virtual reality glasses; pain; anxiety; vital signs; nursing

Outcome Measures

Primary Outcomes (16)

• Pre-colonoscopy state of anxiety

  The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.

  Reported state of anxiety in the first 10 minutes before the colonoscopy procedure

• Pre-colonoscopy pain severity

  Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain

  Reported pain severity in the first 5 minutes before the colonoscopy procedure

• Heart rate before the colonoscopy procedure

  60 to 100 beats per minute is normal.

  Immediately before the colonoscopy procedure

• Blood pressure before the colonoscopy procedure

  90/60 mm Hg to 120/80 mm Hg is normal.

  Immediately before the colonoscopy procedure

• Respiration rate before the colonoscopy procedure

  12 to 18 breaths per minute is normal.

  Immediately before the colonoscopy procedure

• Oxygen saturation (SpO2) before the colonoscopy procedure

  Normal oxygen saturation usually ranges from 95 to 100%.

  Immediately before the colonoscopy procedure

• Heart rate during the colonoscopy procedure

  60 to 100 beats per minute is normal.

  During the colonoscopy procedure

• Blood pressure during the colonoscopy procedure

  90/60 mm Hg to 120/80 mm Hg is normal.

  During the colonoscopy procedure

• Respiration rate during the colonoscopy procedure

  12 to 18 breaths per minute is normal.

  During the colonoscopy procedure

• Oxygen saturation (SpO2) during the colonoscopy procedure

  Normal oxygen saturation usually ranges from 95 to 100%.

  During the colonoscopy procedure

• Heart rate after the colonoscopy procedure

  60 to 100 beats per minute is normal.

  Reported heart rate/per minute in the first 5 minutes after the colonoscopy procedure

• Respiration rate after the colonoscopy procedure

  12 to 18 breaths per minute is normal.

  Reported respiration rate/per minute in the first 5 minutes after the colonoscopy procedure

• Blood pressure after the colonoscopy procedure

  90/60 mm Hg to 120/80 mm Hg is normal.

  Reported blood pressure in the first 5 minutes after the colonoscopy procedure

• Oxygen saturation (SpO2) after the colonoscopy procedure

  Normal oxygen saturation usually ranges from 95 to 100%.

  in the first 5 minutes after the colonoscopy procedure

• Post-colonoscopy pain

  Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain

  Reported pain severity in the first 5 minutes after the colonoscopy procedure

• Pre-colonoscopy state of anxiety

  The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.

  Reported state of anxiety in the first 10 minutes after the colonoscopy procedure

Secondary Outcomes (1)

• Satisfaction status with virtual reality glasses application

  Satisfaction is reported within the first 15 minutes after the colonoscopy procedure.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The experimental group will be asked about their anxiety states with the "State and Trait Anxiety Inventory", their pain conditions 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". Virtual reality glasses will be placed on the patient's head during colonoscopy. The duration of the colonoscopy will vary between 3-10 minutes, videos with music background, park, nature and seaside walks, underwater videos, which the patient chooses, will be watched and the "Vital Signs Tracking Form" Second measurement values will be recorded by making measurements. Immediately after the colonoscopy procedure is completed, "Visual Analogue Scale (VAS)", "Vital Signs 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.

Other: Virtual Reality Glasses

Control Arm

NO INTERVENTION

No application will be made in the control group. during and after colonoscopy and routine treatment and care will be applied.

Interventions

Virtual Reality Glasses OTHER

Virtual Reality Glasses (VRG), one of the methods of distracting attention; widely used in clinical medical care to relieve symptoms by providing the opportunity to create therapeutic environments for the evaluation and treatment of medical conditions. Virtual reality is a computer simulation technique that enables individuals to hear and feel the sounds and corresponding stimuli accompanying the visual image through headphones. The most basic feature that distinguishes virtual reality (VR) glasses from similar applications is that it gives individuals a real feeling. VR has helped to distract patients from mental processing and reduce the amount of pain. Virtual reality glasses, which are inexpensive to apply and use, do not cause side effects, and can be used in the recovery of the individual, are an intervention that can be preferred in nursing practices.

Also known as: Assigned Interventions

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Esra KILINÇ AKMAN: lead

Study Sites (1)

Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ayfer ÖZBAŞ, Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Esra KILINÇ AKMAN, MSC

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Esra KILINÇ AKMAN, MSC

CONTACT

+905548039273; esra.kilincakman@ogr.iu.edu.tr

Ayfer ÖZBAŞ, Prof

CONTACT

+90542 232 09 08; ayferozbas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of Science (MSC) Nurse

Model Details: A randomized controlled study to determine the effects of virtual reality glasses used during the colonoscopy on vital signs, pain, and anxiety levels.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 14, 2021
• Study Start: January 3, 2021
• Primary Completion: June 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)