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Virtual Reality Animation and Ice Massage on The Hoku Point

Sponsor
Kastamonu University (Other)
Overall Status
Completed
CT.gov ID
NCT05850624
Collaborator
(none)
94
Enrollment
1
Location
3
Arms
5
Actual Duration (Months)
18.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ice massage
  • Other: virtual reality animation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction
Actual Study Start Date :
Jun 1, 2022
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. labor pain ["Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)]

      Visual Analogue Scale (VAS)I

    2. labor duration ["Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)]

      Personal Information Form

    3. labor duration [hour of latent phase ( duration can change 8-9 hour)]

      Personal Information Form

    4. labor duration [hour of placental expulsion (duration can change 10 minutes to 30 minutes)]

      Personal Information Form

    5. birth satisfaction [postpartum period up to 24 hours]

      Birth Satisfaction Scale - Revised (BSS-R)

    6. labor pain [active phase up to 20 hours]

      Visual Analogue Scale (VAS) II

    7. labor duration [hour of total delivery (can change 14-18 hours)]

      Personal Information Form

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kastamonu University Kastamonu Turkey 37150

    Sponsors and Collaborators

    • Kastamonu University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Şahika ŞİMŞEK ÇETİNKAYA, Head of Midwifery, Kastamonu University
    ClinicalTrials.gov Identifier:
    NCT05850624
    Other Study ID Numbers:
    • 2022-KAEK-53
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Şahika ŞİMŞEK ÇETİNKAYA, Head of Midwifery, Kastamonu University
    birth pain,
    satisfaction
    ice massage
    virtual reality
    Additional relevant MeSH terms:
    Labor Pain

    Study Results

    No Results Posted as of May 9, 2023