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Completed

NCT Number: NCT05850624

Virtual Reality Animation and Ice Massage on The Hoku Point

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.

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Key information

Conditions

Labor Pain Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kastamonu University

Kastamonu, 37150, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: supportive care

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.

Other names: supportive care

Primary outcomes

  1. labor pain

    Time frame: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)

    Visual Analogue Scale (VAS)I

  2. labor duration

    Time frame: "Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)

    Personal Information Form

  3. labor duration

    Time frame: hour of latent phase ( duration can change 8-9 hour)

    Personal Information Form

  4. labor duration

    Time frame: hour of placental expulsion (duration can change 10 minutes to 30 minutes)

    Personal Information Form

  5. birth satisfaction

    Time frame: postpartum period up to 24 hours

    Birth Satisfaction Scale - Revised (BSS-R)

  6. labor pain

    Time frame: active phase up to 20 hours

    Visual Analogue Scale (VAS) II

  7. labor duration

    Time frame: hour of total delivery (can change 14-18 hours)

    Personal Information Form

Sponsors and collaborators

Lead sponsor

Kastamonu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 9, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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