Virtual Reality Animation and Ice Massage on The Hoku Point

NCT05850624 | Completed

• 1 other identifier: 2022-KAEK-53
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Pain

Keywords

birth pain,; satisfaction; ice massage; virtual reality

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (3)

ice massage

EXPERIMENTAL

ice massage to hoku point for labor pain for 20 minutes

Other: ice massage

virtual animation

EXPERIMENTAL

watching virtual animation for 20 minutes for labor pain

Other: virtual reality animation

Control Group

NO INTERVENTION

receiving standart care

Interventions

ice massage 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

Also known as: supportive care

ice massage

virtual reality animation 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.

Also known as: supportive care

virtual animation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University

Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Personal Satisfaction

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Midwifery

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)