Virtual Reality Animation and Ice Massage on The Hoku Point

NCT ID: NCT05850624

Last Updated: 2023-05-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-11-01

Brief Summary

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The goal of this study was to compare the effects of ice massage and virtual reality animation on labor pain, duration, and satisfaction with delivery.

The main questions aims to answer are:

H1 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor pain.

H2 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor duration.

H3 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' satisfaction.

This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test, chi-square test, Tukey's honestly significant difference test, and will used for data analysis.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ice massage

ice massage to hoku point for labor pain for 20 minutes

Group Type EXPERIMENTAL

ice massage

Intervention Type OTHER

active phase when cervical dilatation was 6-8 cm. Ice will apply to the huko point (LI4 area) which is located on the dorsum of the hand, between the first and second metacarpal bones, between the thumb and the index finger for 20 minutes with an ice pack

virtual animation

watching virtual animation for 20 minutes for labor pain

Group Type EXPERIMENTAL

virtual reality animation

Intervention Type OTHER

cervical dilatation was 6-8 cm. Immediately after the second VAS application, the women will be asked about the video they wanted to watch of the sound of waves in the Ocean, rain falling or blooming trees with virtual reality glass. animation will show for a total of 20 min.

Control Group

receiving standart care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ice massage

active phase when cervical dilatation was 6-8 cm. Ice will apply to the huko point (LI4 area) which is located on the dorsum of the hand, between the first and second metacarpal bones, between the thumb and the index finger for 20 minutes with an ice pack

Intervention Type OTHER

virtual reality animation

cervical dilatation was 6-8 cm. Immediately after the second VAS application, the women will be asked about the video they wanted to watch of the sound of waves in the Ocean, rain falling or blooming trees with virtual reality glass. animation will show for a total of 20 min.

Intervention Type OTHER

Other Intervention Names

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supportive care supportive care

Eligibility Criteria

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Inclusion Criteria

* Term primiparous and singleton pregnancies,
* Longitudinal and vertex position of the fetus,
* Body Mass Index (BMI) below 30,
* cervical dilatation of 0-3 cm,
* who agreed to participate in the study

Exclusion Criteria

* applying pharmacological intervention during labor,
* having a risky pregnancy,
* want to withdraw from the study,
* having ice allergy,
* being visually impaired.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kastamonu University

OTHER

Sponsor Role lead

Responsible Party

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Şahika ŞİMŞEK ÇETİNKAYA

Head of Midwifery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kastamonu University

Kastamonu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022-KAEK-53

Identifier Type: -

Identifier Source: org_study_id

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