Virtual Reality Animation and Ice Massage on The Hoku Point

Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Other: ice massage; Other: virtual reality animation

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kastamonu, Turkey, 37150
    • Kastamonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ice massage; ice massage to hoku point for labor pain for 20 minutes	Other: 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; Other Names: supportive care
Experimental: virtual animation; watching virtual animation for 20 minutes for labor pain	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.; Other Names: supportive care
No Intervention: Control Group; receiving standart care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labor pain	Visual Analogue Scale (VAS)I	"Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)
labor duration	Personal Information Form	"Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)
labor duration	Personal Information Form	hour of latent phase ( duration can change 8-9 hour)
labor duration	Personal Information Form	hour of placental expulsion (duration can change 10 minutes to 30 minutes)
birth satisfaction	Birth Satisfaction Scale - Revised (BSS-R)	postpartum period up to 24 hours
labor pain	Visual Analogue Scale (VAS) II	active phase up to 20 hours
labor duration	Personal Information Form	hour of total delivery (can change 14-18 hours)

Collaborators and Investigators

• Sponsor: Kastamonu University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: satisfaction; virtual reality; ice massage; birth pain,
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2022-KAEK-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I do not want to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No