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he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort

NCT ID: NCT06853821

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-10-01

Brief Summary

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The research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. The hypotheses of the study are:

H0: Comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period.

H1-1: Comfort theory-based care has an effect on pain level in the postpartum period.

H1-2: Comfort theory-based care has an effect on comfort in the postpartum period.

H2-1: The use of virtual reality glasses in the postpartum period has an effect on the level of pain.

H2-2: The use of virtual reality glasses in the postpartum period has an effect on comfort.

Detailed Description

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Although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. In our country, as in many other countries, cesarean delivery rates are quite high.Pain in cesarean births is more severe and lasts longer than in vaginal birth. Along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.In the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving Kolcaba's Comfort Theory-based care to the other. Personal Information Form, Postpartum Comfort Scale, Visual Analogue Scale (VAS) and Virtual Reality Glasses Form will be used as measurement tools.This study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.Increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.

Conditions

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Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants were assigned to groups using the "simple randomization" method. Participants were not informed about which group they were in.

Study Groups

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Control Group

No intervention will be given to the control group.

Pre-Post Test:

A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group (Comfort Theory Based Care

The experimental group will be intervened by providing comfort theory-based care.

Pre-Post Test:

A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals.

Group Type EXPERIMENTAL

Comfort Theory Based Care

Intervention Type OTHER

In the research, this group includes care-based intervention

Experimental Group (Virtual Reality Glasses)

The experimental group will be intervened with virtual reality glasses.

Group Type EXPERIMENTAL

Virtual Reality Glasses

Intervention Type OTHER

In the research, this group includes interventions with virtual reality glasses.

Interventions

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Comfort Theory Based Care

In the research, this group includes care-based intervention

Intervention Type OTHER

Virtual Reality Glasses

In the research, this group includes interventions with virtual reality glasses.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in research
* Having given birth with epidural anesthesia
* Being between the ages of 18-35
* Having given birth within 37-41 weeks of pregnancy
* Having a primiparous cesarean birth

Exclusion Criteria

* Having a normal birth
* Having given birth with general anesthesia
* Having a disability that limits vision, hearing or communication
* Having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayşe Çevirme

Role: STUDY_DIRECTOR

[email protected]

Locations

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Kocaeli State Hospital

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Zeynep Genç Akgün

Role: CONTACT

[email protected]
0090 545 687 14 35

Facility Contacts

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Kocaeli Hospital

Role: primary

[email protected]
0090 262 225 27 00

References

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Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994 Jun;19(6):1178-84. doi: 10.1111/j.1365-2648.1994.tb01202.x.

Reference Type BACKGROUND
PMID: 7930099 (View on PubMed)

Karakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.

Reference Type BACKGROUND

Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

Reference Type BACKGROUND
PMID: 4139420 (View on PubMed)

Other Identifiers

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E-71522473-050.04-363990-135

Identifier Type: -

Identifier Source: org_study_id