Acupressure and Comfort at Childbirth

NCT05407103 | Completed DMC

• 1 other identifier: 21.05.2020-15
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Labor

Keywords

Pain, Labor, Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Labor pain

  through study completion, an average of 1month

Study Arms (3)

Cold Acupressure Group

EXPERIMENTAL

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.

Other: Cold Acupressure

Warm Acupressure Group

EXPERIMENTAL

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.

Other: Warm Acupressure

Control Group

NO INTERVENTION

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.

Interventions

Cold Acupressure OTHER

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.

Cold Acupressure Group

Warm Acupressure OTHER

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.

Warm Acupressure Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Having any of the above criteria

Sponsors & Collaborators

• Serap Ozturk Altinayak: lead

Study Sites (1)

Health Research and Training Hospital of Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 7, 2022
• Study Start: August 24, 2020
• Primary Completion: March 31, 2021
• Study Completion: February 21, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)