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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05407103
Other study ID # 21.05.2020-15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2020
Est. completion date February 21, 2022

Study information

Verified date June 2022
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date February 21, 2022
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cold Acupressure
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.
Warm Acupressure
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.

Locations

Country Name City State
Turkey Health Research and Training Hospital of Tokat Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Serap Ozturk Altinayak

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comfort 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 Labor pain 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
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