Episiotomy; DehiscenceNCT05578989
The Effect of Virtual Reality Glasses Applied During Vaginal Incision Suturing on Pain and Satisfaction
A study testing Virtual reality glasses in people with Episiotomy; Dehiscence, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy; Dehiscence
- What is being tested?
- Virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 2 Aug 2022
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be between the ages of 18-49
- Speak and understand Turkish
- Volunteering to participate in the study
- Being a primiparous (first-time woman) pregnant
- Being in the low pregnancy risk group without obstetric complications (bleeding, unreliable fetal heart rate…) at all stages of delivery
- To have given spontaneous delivery with a medio-lateral episiotomy incision in the hospital at the time of the study.
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- Not having vision, hearing and perception problems
- No diagnosis or history of mental illness
- Not having any signs of infection such as vaginal redness, swelling
- Not be allergic to latex and local anesthetic drugs
- No communication problem,
Who cannot join
- Apgar score <7 in 1 minute and 5 minutes
- Having a neonatal anomaly
- Unusual use of lidocaine during episiotomy repair (lidocaine greater than 5 ml 2%)
- Those who did not meet the inclusion criteria, did not fill out the form and stopped participating in the study.
- Those with headaches
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necip Fazıl City Hospital/ Gynecology and Children
Kahramanmaraş, 46050
About this study
Official title: The Effect of Virtual Reality Glasses Applied During Episiotomy on Pain and Satisfaction: Single Blind Randomized Controlled Trial
The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure. The sample consisted of 50 pregnant woman of whom 25 were in the control group and 25 were determined by randomization among primiparous pregnant woman who met the reasearch's criteria and agreed to participate in the study.
Read the detailed description
Objective: The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure.
Method: The research population consisted of 50 primiparous pregnant women who applied to the delivery room of Necip Fazıl City Hospital Gynecology and Child Additional Service Building between 15 June 2021 and 15 December 2021 for vaginal delivery. Data were collected with the Mother Identification Form and Visual Analogum Scales (VAS) Pain - Satisfaction Evaluation Forms. During the episiotomy repair procedure, 5 ml of lidocaine was administered to the patients in the intervention group; A video with music was watched with virtual reality glasses for an average of 10 minutes, just before starting the process and throughout the process. No application was made to the mothers in the control group, except for 5 ml of lidocaine, which was applied during episiotomy repair. In the evaluation of the data, mean, standard deviation, percentage and number values are given. Student's t test was used to compare normally distributed variables in two groups, and Mann Whitney U test was used to compare non-normally distributed variables in two groups. In testing the variables in different groups and times, repeated measures of variance analysis were applied. Relationships between categorical variables were tested with CI-square test, and relations between non-normally distributed numerical variables were tested with Spearman rank correlation coefficient. SPSS 22.0 Windows version package program was used in the analysis. P<0.05 was considered significant.
- Conditions
- Episiotomy; Dehiscence
- Being tested
- Virtual reality glasses
- Keywords
- Obstetrics, Episiotomy, Virtual reality, Pain, Satisfaction
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesDevice
watching a video with music with virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| Group watching video with virtual reality glasses | Experimental | Women in the intervention group watched a video with virtual reality glasses during the episiotomy. (25 women) Receives: Device: Virtual reality glasses |
| Comparisongroup that does not use virtual glasses | No intervention | The women in the control group were treated with without watching videos during the episiotomy. (25 women) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is a scale used to measure subjective experiences. In the form of a 0-10 cm ruler, one end of the scale indicates 0 painlessness and the other end 10 indicates the most severe degree of pain intensity. The degree of pain intensity was evaluated by marking the pain perceived by the woman on the ruler.
Measured: 10-15 munites.
Secondary outcomes (1)
Visual Analogue Scale
It is a scale used to measure subjective experiences. It was used to assess satisfaction after episiotomy. One end of the scale, in the form of a 0-10 cm ruler, indicates dissatisfaction at all, and the other end of 10 indicates the highest degree of satisfaction. The satisfaction level of the woman was evaluated by marking the number on the ruler. Satisfaction was measured in the first 1-hour period immediately after the episiotomy.
Measured: 5 munites.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start15 Aug 2021
- Primary completion15 Dec 2021
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy; DehiscenceStudies 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merva Orhan, Kahramanmaras Sutcu Imam University
- Investigators
- Aysel Bülez, Assist. Prof., Study chair, Kahramanmaraş Sütçü İmam University institute of health sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578989
- Sponsor's protocol ID
- 135790
- Status last verified
- Oct 2022
- First submitted
- 19 Jul 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Applied During Episiotomy on Pain and Satisfaction: Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05578989
- Acronym / sponsor ID
- 135790
- Conditions
- Episiotomy; Dehiscence
- Keywords
- Obstetrics, Episiotomy, Virtual reality, Pain, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 13 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.
The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure. The sample consisted of 50 pregnant woman of whom 25 were in the control group and 25 were determined by randomization among primiparous pregnant woman who met the reasearch's criteria and agreed to participate in the study.
Detailed description
Objective: The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure.
Method: The research population consisted of 50 primiparous pregnant women who applied to the delivery room of Necip Fazıl City Hospital Gynecology and Child Additional Service Building between 15 June 2021 and 15 December 2021 for vaginal delivery. Data were collected with the Mother Identification Form and Visual Analogum Scales (VAS) Pain - Satisfaction Evaluation Forms. During the episiotomy repair procedure, 5 ml of lidocaine was administered to the patients in the intervention group; A video with music was watched with virtual reality glasses for an average of 10 minutes, just before starting the process and throughout the process. No application was made to the mothers in the control group, except for 5 ml of lidocaine, which was applied during episiotomy repair. In the evaluation of the data, mean, standard deviation, percentage and number values are given. Student's t test was used to compare normally distributed variables in two groups, and Mann Whitney U test was used to compare non-normally distributed variables in two groups. In testing the variables in different groups and times, repeated measures of variance analysis were applied. Relationships between categorical variables were tested with CI-square test, and relations between non-normally distributed numerical variables were tested with Spearman rank correlation coefficient. SPSS 22.0 Windows version package program was used in the analysis. P<0.05 was considered significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group watching video with virtual reality glasses | Experimental | Device: Virtual reality glassesWomen in the intervention group watched a video with virtual reality glasses during the episiotomy. (25 women) |
| Comparisongroup that does not use virtual glasses | No intervention | –The women in the control group were treated with without watching videos during the episiotomy. (25 women) |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- To be between the ages of 18-49
- Speak and understand Turkish
- Volunteering to participate in the study
- Being a primiparous (first-time woman) pregnant
- Being in the low pregnancy risk group without obstetric complications (bleeding, unreliable fetal heart rate…) at all stages of delivery
Key exclusion criteria (5 listed)
- Apgar score <7 in 1 minute and 5 minutes
- Having a neonatal anomaly
- Unusual use of lidocaine during episiotomy repair (lidocaine greater than 5 ml 2%)
- Those who did not meet the inclusion criteria, did not fill out the form and stopped participating in the study.
- Those with headaches
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 |
|---|---|---|
| Virtual reality glasseswatching a video with music with virtual reality glasses. | Device | Group watching video with virtual reality glasses |
Primary outcome
Visual Analogue Scale
Time frame: 10-15 munites.
It is a scale used to measure subjective experiences. In the form of a 0-10 cm ruler, one end of the scale indicates 0 painlessness and the other end 10 indicates the most severe degree of pain intensity. The degree of pain intensity was evaluated by marking the pain perceived by the woman on the ruler.
1 secondary outcome
Visual Analogue Scale
Time frame: 5 munites.
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 13 Oct 2022.
Related trials for Episiotomy; Dehiscence
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Aysel Bülez, Assist. Prof. study chair
Kahramanmaraş Sütçü İmam University institute of health sciences.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses in people with Episiotomy; Dehiscence, run by Kahramanmaras Sutcu Imam 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 11 inclusion and 5 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 13 Oct 2022. 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?
Visual Analogue Scale (time frame: 10-15 munites.). 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 13 Oct 2022.