Acupressure and Comfort at Childbirth

Sponsor

Serap Ozturk Altinayak (Other)

Overall Status

Completed

CT.gov ID

NCT05407103

Collaborator

(none)

129

Enrollment

Location

Arms

17.9

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Labor	Other: Cold Acupressure Other: Warm Acupressure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial

Actual Study Start Date :

Aug 24, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Feb 21, 2022

Arms and Interventions

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.	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.
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.	Other: 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.
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.

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.

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.

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.

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

Comfort [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

Secondary Outcome Measures

Labor pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Research and Training Hospital of Tokat Gaziosmanpaşa University	Tokat		Turkey

Sponsors and Collaborators

Serap Ozturk Altinayak

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Serap Ozturk Altinayak, Assistant professor, Ondokuz Mayıs University

ClinicalTrials.gov Identifier:

NCT05407103

Other Study ID Numbers:

21.05.2020-15

First Posted:

Jun 7, 2022

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Serap Ozturk Altinayak, Assistant professor, Ondokuz Mayıs University

Pain, Labor, Comfort

Additional relevant MeSH terms:

Labor Pain

Study Results

No Results Posted as of Jun 7, 2022