- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977713
Delivery Pain and Postpartum Comfort
July 15, 2021 updated by: Ayca Solt Kirca, Kırklareli University
Effects of Acupressure and Shower Applied in the Delivery on the Intensity of Labor Pain and Postpartum Comfort
In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Acupressure and shower are methods that can help reduce pain severity.
This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort.
This study was a randomized controlled trial (RCT).
This study was the control group consisted of 40 pregnant women, while the experimental groups (acupressure and shower) consisted of 80 pregnant women in total.
The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm).
The control group only received routine labour care.
A maternal information form (MIF), the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data.
CONSORT checklist was used to report the current study.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34180
- Medipol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- The inclusion criteria were being 20-40 years of age;
- Having a foetus in vertex presentation
- Having a foetus weighing 2.5-4 kg, as determined through ultrasonography
- Being primiparous
- Being between 37 and 42 gestational weeks with a single foetus
- Having planned to have a spontaneous vaginal delivery
- Not having used nonpharmacological pain control methods previously
- Having a cervical dilation less than 5 cm (Dabiri et al., 2014)
- Not having received analgesia or anaesthesia.
Exclusion Criteria:
- Were having a systemic disease during pregnancy (gestational diabetes, hypertension)
- Taking medication regularly
- Having a problem that prevented the woman from communicating
- Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)
- Requiring an operative vaginal delivery (forceps, vacuum)
- Receiving pharmacological interventions for labour pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupressure group
In the acupressure uterine contractions were checked before the care application began.
Acupressure was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm.
This method was applied 18 times during uterine contractions.
The application stopped at the end of each contraction and resumed once another contraction started.
No application was performed between contractions.
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A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position.
The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants
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Experimental: Shower Group
The shower group, uterine contractions were checked before the care application began.
A shower was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm.
This method was applied 18 times during uterine contractions.
The application stopped at the end of each contraction and resumed once another contraction started.
No application was performed between contractions.
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During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes).
The water's temperature was between 22°C and 26°C.
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No Intervention: Control group
The women in the control group underwent routine hospital care.
They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduce labor pain
Time Frame: Evaluation was done until delivery (on average between 8-12 hours)
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The participants were applicated acupressure, and shower as for birth pain.
Pain has been evaluated with VASP.
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Evaluation was done until delivery (on average between 8-12 hours)
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Postpartum comfort levels
Time Frame: 2 hours after birth
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Postpartum comfort levels of the groups who received acupressure and shower in the postpartum period were evaluated.Postpartum comfort level has been evaluated with PPCQ.
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2 hours after birth
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A maternal information form
Time Frame: before birth
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This form consisted of 13 items asking for the participants' sociodemographic characteristics
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before birth
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Visual Analog Scale for Pain (VASP)
Time Frame: Evaluation was done until delivery (on average between 8-12 hours)
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This scale is a 0-10 cm ruler developed by Bond and Pilowsky (Hawker et al., 2011; Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Bond and Pilowsky, 1996).
VASP is a 10 cm ruler which assessment with "no pain" at one end and "worst pain" at the other end.
A Turkish validity and reliability study of the VASP was performed by Aslan and Öztürk (Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Aslan, 2004).
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Evaluation was done until delivery (on average between 8-12 hours)
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Postpartum Comfort Questionnaire (PPCQ)
Time Frame: 2 hours after birth
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The 48-item General Comfort Scale, developed by Kolcaba (Kolcaba, 1994), was first adapted into Turkish in 2008 by Kuğuoğlu and Karabacak, who also conducted a Turkish validity and reliability study on the scale (Kuğuoğlu and Karabacak, 2008).
Based on the Turkish version of the GCS, Karakaplan and Yıldız (Karakaplan and Yıldız, 2010) developed the PPCQ.
The PPCQ is a 5-point questionnaire with 34 items.
Participants give items between 1 (strongly agree) and 5 points (strongly disagree).
The lowest score possible is 34, and the highest score is 170, with higher scores indicating higher comfort levels.
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2 hours after birth
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Evalution labour pain
Time Frame: Evaluation was done until delivery (on average between 8-12 hours)
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VASP was evaluated before and after acupressure and shower applications.
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Evaluation was done until delivery (on average between 8-12 hours)
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Evalution postpartum comfort
Time Frame: 2 hours after birth
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Postpartum Comfort levels were evaluated in the postpartum period.
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2 hours after birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: AYCA SOLT KIRCA, Phd, Kırklareli University
- Principal Investigator: DERYA KANZA GÜL, Md, Phd, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
January 25, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 15, 2021
First Posted (Actual)
July 27, 2021
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KırklareliAS-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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