Back to resultsAcupressure and Comfort at Childbirth
Primary Purpose
Pain, Labor
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold Acupressure
Warm Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Labor focused on measuring Pain, Labor, Comfort
Eligibility Criteria
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
Sites / Locations
- Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cold Acupressure Group
Warm Acupressure Group
Control Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05407103
Brief Title
Acupressure and Comfort at Childbirth
Official Title
The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
February 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Serap Ozturk Altinayak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Labor
Keywords
Pain, Labor, Comfort
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold Acupressure Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Warm Acupressure Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cold Acupressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Warm Acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comfort
Description
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
Time Frame
through study completion, an average of 1month
Secondary Outcome Measure Information:
Title
Labor pain
Description
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.
Time Frame
through study completion, an average of 1month
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Health Research and Training Hospital of Tokat Gaziosmanpaşa University
City
Tokat
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupressure and Comfort at Childbirth
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