- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407103
Acupressure and Comfort at Childbirth
The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial
Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.
Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tokat, Turkey
- Health Research and Training Hospital of Tokat Gaziosmanpaşa University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being a primipara
- Having intact membranes
- No skin diseases (such as urticaria...),
- No use of narcotic drugs
- Having a term pregnancy
- Having a single fetus at vertex position
- Planning to have vaginal delivery
- Having contractions and ongoing regular augmentation
- Having recent augmentation starting periods
- Being in the latent phase (0-3 cm dilatation)
- Having no history of high-risk pregnancy
- Not using analgesic drugs to reduce pain during delivery
- Having no systemic and neurologic diseases
- Having no contraction anomaly (hypotonic or hypertonic contractions)
Exclusion Criteria:
• Having any of the above criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cold Acupressure Group
Personal information form (PIF ) , Labor Monitoring Form (LMF), Visual Analog Scale (VAS), and Childbirth Comfort Questionnaire (CCQ) as pre-test during the latent phase before going about the cold acupressure. Next, she applied the cold acupressure pouches on the respective cold group on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times. Last, posttest took place. Cold group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after cold group to monitor how they were feeling. |
For the cold acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference.
Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout.
Lastly, the cold acupressure pouches were kept in a freezer for 40 minutes.
|
Experimental: Warm Acupressure Group
PIF, LMF, VAS, and CCQ as pre-test during the latent phase before going about the warm acupressure. Next, she applied the warm acupressure pouches on the respective warm groups on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times. Last, posttest took place. Warm group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after warm group to monitor how they were feeling. |
For the warm acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference.
Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout.
Lastly, the warm acupressure pouches were heated in a microwave at 600 W for one minute.
|
No Intervention: Control Group
The researcher ran PIF, LMF, VAS, and CCQ as pre-test during the latent phase.
No intervention was applied to the control group.
Last, posttest took place.
Control group was given VAS and CCQ during transition phase of dilation between contractions.
The researchers then filled out LMF after warm group to monitor how they were feeling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort
Time Frame: through study completion, an average of 1month
|
Childbirth Comfort Questionnaire (CCQ); Each item ranks between 1 and 5 points: 1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, and 5=Completely agree.
Thus, the lowest and highest scores are 9 and 45 points, respectively.
The higher the score one earns, the more comfortable they are; the lower the score, the exact opposite
|
through study completion, an average of 1month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Labor pain
Time Frame: through study completion, an average of 1month
|
Visual Analog Scale (VAS); It is a 10-cm one-dimensional ruler; written on one end is "no pain"; on the other is "worst pain."
For the purpose of this study, the researchers used VAS vertically in this study, in line with the recommendations of other studies, who suggest that individuals understand VAS better when applied vertically.
|
through study completion, an average of 1month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.05.2020-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Labor
-
Cukurova UniversityRecruitingLabor Pain, Labor Perception, Hormone Levels and Childbirth ComfortTurkey
-
Soovu Labs Inc.Virginia Mason Hospital/Medical CenterNot yet recruiting
-
Bogomolets National Medical UniversityCompleted
-
Martin-Luther-Universität Halle-WittenbergRecruiting
-
Maimonides Medical CenterTerminated
-
Aretaieio HospitalRecruitingLabor Pain | Pain, Labor | EpiduralGreece
-
Mashhad University of Medical SciencesTerminatedDecrease Labor Pain
-
Amasya UniversityAtaturk UniversityNot yet recruitingSatisfaction, Patient | Pain, Labor
-
University Medical Centre LjubljanaCompletedLabor Pain | Labor; Prolonged, First Stage | Labor; Prolonged, Second StageSlovenia
-
University Hospital "Sestre Milosrdnice"CompletedPain, Labor | Acupuncture, Ear | Episiotomy; ComplicationsCroatia
Clinical Trials on Cold Acupressure
-
Chang-Hua HospitalChina Medical University HospitalUnknownInsomnia | Anxiety | Menopause | Auricular AcupressureTaiwan
-
Mersin UniversityRecruiting
-
Mersin UniversityCompleted
-
Cairo UniversityCompleted
-
University of MichiganNational Cancer Institute (NCI)CompletedBreast Cancer | Sleepiness | Chronic FatigueUnited States
-
University of MichiganCompleted
-
China Medical University HospitalNot yet recruiting
-
Guangdong Provincial Hospital of Traditional Chinese...Completed
-
Mersin UniversityRecruitingPain, Postoperative | Anxiety | Hemodynamic InstabilityTurkey