Labor PainNCT05850624
Virtual Reality Animation and Ice Massage on The Hoku Point
A study testing ice massage and virtual reality animation in people with Labor Pain, run by Kastamonu University at 1 site in Turkey (Türkiye).
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'… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- ice massage and virtual reality animation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- applying pharmacological intervention during labor,
- having a risky pregnancy,
- want to withdraw from the study,
- having ice allergy,
- being visually impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Being tested
- ice massage, virtual reality animation
- Keywords
- birth pain,, satisfaction, ice massage, virtual reality
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice massageOther
Also called supportive care
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 animationOther
Also called supportive care
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.
| Study group | Role | What they receive |
|---|---|---|
| ice massage | Experimental | ice massage to hoku point for labor pain for 20 minutes Receives: Other: ice massage |
| virtual animation | Experimental | watching virtual animation for 20 minutes for labor pain Receives: Other: virtual reality animation |
| Control Group | No intervention | receiving standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
labor pain
Visual Analogue Scale (VAS)I
Measured: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)
labor duration
Personal Information Form
Measured: "Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)
labor duration
Personal Information Form
Measured: hour of latent phase ( duration can change 8-9 hour)
labor duration
Personal Information Form
Measured: hour of placental expulsion (duration can change 10 minutes to 30 minutes)
birth satisfaction
Birth Satisfaction Scale - Revised (BSS-R)
Measured: postpartum period up to 24 hours
labor pain
Visual Analogue Scale (VAS) II
Measured: active phase up to 20 hours
labor duration
Personal Information Form
Measured: hour of total delivery (can change 14-18 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850624
- Sponsor's protocol ID
- 2022-KAEK-53
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction
- ClinicalTrials.gov ID
- NCT05850624
- Acronym / sponsor ID
- 2022-KAEK-53
- Conditions
- Labor Pain
- Keywords
- birth pain,, satisfaction, ice massage, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ice massage | Experimental | Other: ice massageice massage to hoku point for labor pain for 20 minutes |
| virtual animation | Experimental | Other: virtual reality animationwatching virtual animation for 20 minutes for labor pain |
| Control Group | No intervention | –receiving standart care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- applying pharmacological intervention during labor,
- having a risky pregnancy,
- want to withdraw from the study,
- having ice allergy,
- being visually impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ice massageAlso: supportive careactive 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 | ice massage |
| virtual reality animationAlso: supportive carecervical 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 | virtual animation |
Primary outcome
labor pain
Time frame: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)
Visual Analogue Scale (VAS)I
labor duration
Time frame: "Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)
Personal Information Form
labor duration
Time frame: hour of latent phase ( duration can change 8-9 hour)
Personal Information Form
labor duration
Time frame: hour of placental expulsion (duration can change 10 minutes to 30 minutes)
Personal Information Form
birth satisfaction
Time frame: postpartum period up to 24 hours
Birth Satisfaction Scale - Revised (BSS-R)
labor pain
Time frame: active phase up to 20 hours
Visual Analogue Scale (VAS) II
labor duration
Time frame: hour of total delivery (can change 14-18 hours)
Personal Information Form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. I do not want to make individual participant data (IPD) available to other researchers.
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ice massage and virtual reality animation in people with Labor Pain, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
labor pain (time frame: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.