Virtual Reality Animation and Ice Massage on The Hoku Point

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850624
• Other study ID #: 2022-KAEK-53
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2023
• Source: Kastamonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Turkey	Kastamonu University	Kastamonu

Sponsors (1)

Lead Sponsor	Collaborator
Kastamonu University

Country where clinical trial is conducted

Turkey, 

Outcome

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