Patient Relations, NurseNCT05587946
The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
A study testing Experimental group in people with Patient Relations, Nurse and Nurse's Role, run by İBRAHİM NAS at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Relations, Nurse, Nurse's Role, Supportive Care
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 1 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older,
- who can read and write Turkish,
- without mental problems,
- Having no vision, hearing or perception problems,
- Diagnostic endoscopy was performed,
- No sedation before and during the procedure
Show all 11Show fewer
- who volunteered to participate in the study,
- Those who have not taken analgesics in the last 8 hours
- Qualitative research inclusion criteria;
- in the experimental group,
- who volunteered to participate in the research
Who cannot join
- sedation applied,
- who want to withdraw from the study,
- Patients using analgesics or anti-anxiety medications before and during the procedure
- Those in the control group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University, Faculty of Health Sciences, Department of Nursing, Van, Turkey
Van
About this study
In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.
Read the detailed description
Objective: In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.
The research was carried out in the endoscopy unit of a university hospital in Van between November 2022 and March 2023. This research, in which an exploratory sequential mixed design was used, consists of two stages. In the research, the quantitative phase, in which a pretest-posttest design, randomized controlled, experimental method was used, was completed with 75 patients, and the qualitative phase, in which the phenomenological/phenomenological design was used, was completed with 19 patients. Patient introduction form, state anxiety scale, pain visual comparison scale, patient follow-up form and semi-structured interview form were used to collect data. IBM SPSS V23 program (quantitative) and inductive qualitative content analysis (qualitative) were used to analyze the data.
- Conditions
- Patient Relations, Nurse, Nurse's Role, Supportive Care
- Being tested
- Experimental group
- Keywords
- Endoscopy, virtual reality, pain, anxiety, vital signs
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called Girişim grubu
In recent years, virtual reality has been widely used as a distraction practice in clinical medical care to relieve pain. Virtual reality is a method of viewing computer images to isolate the individual from real life for a while. Virtual reality glasses, consisting of a head-mounted display and glasses connected to a mobile phone, is a computer technology that creates a 3D environment. The virtual reality application, which was originally designed for entertainment purposes, started to be used in the medical field to reduce pain during invasive procedures in parallel with the developments in computer technologies. It is preferred in clinical practice as an easily accessible, non-invasive and inexpensive method.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | 1. Implementation steps 1-4 of the Control Group will be done.
2. The patient will be informed about the virtual reality application.
3. The patient will be told that they can remove their glasses at any time and stop participating in the study.
4. 2 minutes before the endoscopy process starts, the previously determined video will be started by putting on the Virtual Reality Glasses.
5. Glasses will be worn from the beginning to the end of the procedure.
6. The patient will be observed during the procedure. The data obtained during the observation will be noted.
7. After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be re-applied and vital signs will be measured and recorded in the Patient Follow-up Form.
8. After the endoscopy procedure, patients will be given an interview appointment on the same day to collect the data of the qualitative part of the study.
9. "Semi-Structured Interview Form" will be applied in the interview. Receives: Other: Experimental group |
| Control group | No intervention | 1. Hands will be washed. 2. The right patient will be determined, the procedure will be explained to the patient and permission will be obtained. 3. A "Patient Identification Form" will be applied to the individual before the endoscopy procedure. 4. Before the endoscopy procedure; "State Anxiety Scale" will be applied in the first 10 minutes, and "Visual Comparison Scale" will be applied in the first 5 minutes. Vital signs will be measured within the first 5 minutes and recorded on the Patient Follow-up Form. Then the individual will be taken to the endoscopy procedure. 5. The patient will be observed during the procedure. The data obtained during the observation will be noted. 6. After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be applied again and vital signs will be measured and recorded in the Patient Follow-up Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety state before endoscopy
The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.
Measured: Anxiety state reported within the first 10 minutes before the endoscopy procedure
Pain intensity before endoscopy
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain
Measured: Pain intensity reported within the first 5 minutes prior to the endoscopy procedure
Heart rate before the endoscopy procedure
60 to 100 beats per minute is normal.
Measured: Just before the endoscopy procedure
Blood pressure before the endoscopy procedure
90/60 mm Hg to 120/80 mm/Hg is normal.
Measured: Just before the endoscopy procedure
Respiration rate before the endoscopy procedure
12 to 20 breaths per minute is normal.
Measured: Just before the endoscopy procedure
Body temperature before the endoscopy procedure
Normal Body temperature; 36 to 37-5 degrees is normal.
Measured: Just before the endoscopy procedure
Oxygen saturation (SpO2) before the endoscopy procedure
Normal oxygen saturation usually ranges from 95% to 100%.
Measured: Just before the endoscopy procedure
Oxygen saturation (SpO2) after endoscopy procedure
Normal oxygen saturation usually ranges from 95% to 100%.
Measured: within first 5 minutes after endoscopy procedure
Body temperature after endoscopy procedure
Normal Body temperature; 36 to 37-5 degrees is normal.
Measured: within first 5 minutes after endoscopy procedure
Respiration rate after endoscopy procedure
12 to 20 breaths per minute is normal.
Measured: Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure
Blood pressure after the endoscopy procedure
90/60 mm Hg to 120/80 mm/Hg is normal.
Measured: within first 5 minutes after the endoscopy procedure
Heart rate after the endoscopy procedure
60 to 100 beats per minute is normal.
Measured: Heart rate per minute reported in the first 5 minutes after the endoscopy procedure
Post-endoscopy pain
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain
Measured: Pain severity reported in the first 5 minutes after the endoscopy procedure
Post-endoscopy anxiety state
The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.
Measured: Anxiety state reported within the first 10 minutes after the endoscopy procedure
Secondary outcomes (4)
Patient opinions on endoscopy
General thoughts of the patient about endoscopy
Measured: Two hours after endoscopy
Patient opinions on virtual reality glasses and its application
General thoughts of the patient about the use of virtual reality glasses during endoscopy
Measured: Two hours after endoscopy
Patient opinions on the effect of virtual reality application on pain
Patient opinions on the effect of virtual reality application on pain
Measured: Two hours after endoscopy
Patient opinions on the effect of virtual reality application on anxiety
Patient opinions on the effect of virtual reality application on anxiety
Measured: Two hours after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start15 Jan 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Relations, NurseStudies of the same condition, open and under way.
- 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
- The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İBRAHİM NAS
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, İBRAHİM NAS, Ataturk University
- Investigators
- GÜLAY İPEK ÇOBAN, Prof.Dr., Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587946
- Sponsor's protocol ID
- D. Tez
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05587946
- Acronym / sponsor ID
- D. Tez
- Conditions
- Patient Relations, Nurse, Nurse's Role, Supportive Care
- Keywords
- Endoscopy, virtual reality, pain, anxiety, vital signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- İBRAHİM NASUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 20 Oct 2022 (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.
In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.
Detailed description
Objective: In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.
The research was carried out in the endoscopy unit of a university hospital in Van between November 2022 and March 2023. This research, in which an exploratory sequential mixed design was used, consists of two stages. In the research, the quantitative phase, in which a pretest-posttest design, randomized controlled, experimental method was used, was completed with 75 patients, and the qualitative phase, in which the phenomenological/phenomenological design was used, was completed with 19 patients. Patient introduction form, state anxiety scale, pain visual comparison scale, patient follow-up form and semi-structured interview form were used to collect data. IBM SPSS V23 program (quantitative) and inductive qualitative content analysis (qualitative) were used to analyze the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Other: Experimental group1. Implementation steps 1-4 of the Control Group will be done. 2. The patient will be informed about the virtual reality application. 3. The patient will be told that they can remove their glasses at any time and stop participating in the study. 4. 2 minutes before the endoscopy process starts, the previously determined video will be started by putting on the Virtual Reality Glasses. 5. Glasses will be worn from the beginning to the end of the procedure. 6. The patient will be observed during the procedure. The data obtained during the observation will be noted. 7. After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be re-applied and vital signs will be measured and recorded in the Patient Follow-up Form. 8. After the endoscopy procedure, patients will be given an interview appointment on the same day to collect the data of the qualitative part of the study. 9. "Semi-Structured Interview Form" will be applied in the interview. |
| Control group | No intervention | –1. Hands will be washed. 2. The right patient will be determined, the procedure will be explained to the patient and permission will be obtained. 3. A "Patient Identification Form" will be applied to the individual before the endoscopy procedure. 4. Before the endoscopy procedure; "State Anxiety Scale" will be applied in the first 10 minutes, and "Visual Comparison Scale" will be applied in the first 5 minutes. Vital signs will be measured within the first 5 minutes and recorded on the Patient Follow-up Form. Then the individual will be taken to the endoscopy procedure. 5. The patient will be observed during the procedure. The data obtained during the observation will be noted. 6. After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be applied again and vital signs will be measured and recorded in the Patient Follow-up Form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years and older,
- who can read and write Turkish,
- without mental problems,
- Having no vision, hearing or perception problems,
- Diagnostic endoscopy was performed,
Key exclusion criteria (4 listed)
- sedation applied,
- who want to withdraw from the study,
- Patients using analgesics or anti-anxiety medications before and during the procedure
- Those in the control group
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 |
|---|---|---|
| Experimental groupAlso: Girişim grubuIn recent years, virtual reality has been widely used as a distraction practice in clinical medical care to relieve pain. Virtual reality is a method of viewing computer images to isolate the individual from real life for a while. Virtual reality glasses, consisting of a head-mounted display and glasses connected to a mobile phone, is a computer technology that creates a 3D environment. The virtual reality application, which was originally designed for entertainment purposes, started to be used in the medical field to reduce pain during invasive procedures in parallel with the developments in computer technologies. It is preferred in clinical practice as an easily accessible, non-invasive and inexpensive method. | Other | Intervention/treatment |
Primary outcome
Anxiety state before endoscopy
Time frame: Anxiety state reported within the first 10 minutes before the endoscopy procedure
The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.
Pain intensity before endoscopy
Time frame: Pain intensity reported within the first 5 minutes prior to the endoscopy procedure
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain
Heart rate before the endoscopy procedure
Time frame: Just before the endoscopy procedure
60 to 100 beats per minute is normal.
Blood pressure before the endoscopy procedure
Time frame: Just before the endoscopy procedure
90/60 mm Hg to 120/80 mm/Hg is normal.
Respiration rate before the endoscopy procedure
Time frame: Just before the endoscopy procedure
12 to 20 breaths per minute is normal.
Body temperature before the endoscopy procedure
Time frame: Just before the endoscopy procedure
Normal Body temperature; 36 to 37-5 degrees is normal.
Oxygen saturation (SpO2) before the endoscopy procedure
Time frame: Just before the endoscopy procedure
Normal oxygen saturation usually ranges from 95% to 100%.
Oxygen saturation (SpO2) after endoscopy procedure
Time frame: within first 5 minutes after endoscopy procedure
Normal oxygen saturation usually ranges from 95% to 100%.
Body temperature after endoscopy procedure
Time frame: within first 5 minutes after endoscopy procedure
Normal Body temperature; 36 to 37-5 degrees is normal.
Respiration rate after endoscopy procedure
Time frame: Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure
12 to 20 breaths per minute is normal.
Blood pressure after the endoscopy procedure
Time frame: within first 5 minutes after the endoscopy procedure
90/60 mm Hg to 120/80 mm/Hg is normal.
Heart rate after the endoscopy procedure
Time frame: Heart rate per minute reported in the first 5 minutes after the endoscopy procedure
60 to 100 beats per minute is normal.
Post-endoscopy pain
Time frame: Pain severity reported in the first 5 minutes after the endoscopy procedure
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain
Post-endoscopy anxiety state
Time frame: Anxiety state reported within the first 10 minutes after the endoscopy procedure
The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.
4 secondary outcomes
Patient opinions on endoscopy
Time frame: Two hours after endoscopy
Patient opinions on virtual reality glasses and its application
Time frame: Two hours after endoscopy
Patient opinions on the effect of virtual reality application on pain
Time frame: Two hours after endoscopy
Patient opinions on the effect of virtual reality application on anxiety
Time frame: Two hours after endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
GÜLAY İPEK ÇOBAN, Prof.Dr. principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Patient Relations, Nurse and Nurse's Role, run by İBRAHİM NAS 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 11 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?
Results are not available in the source record.
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?
Anxiety state before endoscopy (time frame: Anxiety state reported within the first 10 minutes before the endoscopy procedure). The study lists 14 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 3 Nov 2023.