Back to resultsDelivery Pain and Postpartum Comfort
Primary Purpose
Labor Pain, Hydrotherapy, Acupressure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Shower
Sponsored by
About this trial
This is an interventional prevention trial for Labor Pain focused on measuring labor pain, shower, acupressure, midwife, postpartum comfort
Eligibility Criteria
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.
Sites / Locations
- Medipol University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Acupressure group
Shower Group
Control group
Arm Description
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.
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.
The women in the control group underwent routine hospital care. They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain.
Outcomes
Primary Outcome Measures
Reduce labor pain
The participants were applicated acupressure, and shower as for birth pain. Pain has been evaluated with VASP.
Postpartum comfort levels
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.
A maternal information form
This form consisted of 13 items asking for the participants' sociodemographic characteristics
Visual Analog Scale for Pain (VASP)
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).
Postpartum Comfort Questionnaire (PPCQ)
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.
Evalution labour pain
VASP was evaluated before and after acupressure and shower applications.
Evalution postpartum comfort
Postpartum Comfort levels were evaluated in the postpartum period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04977713
Brief Title
Delivery Pain and Postpartum Comfort
Official Title
Effects of Acupressure and Shower Applied in the Delivery on the Intensity of Labor Pain and Postpartum Comfort
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Hydrotherapy, Acupressure, Postpartum Period
Keywords
labor pain, shower, acupressure, midwife, postpartum comfort
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Shower Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The women in the control group underwent routine hospital care. They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Shower
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduce labor pain
Description
The participants were applicated acupressure, and shower as for birth pain. Pain has been evaluated with VASP.
Time Frame
Evaluation was done until delivery (on average between 8-12 hours)
Title
Postpartum comfort levels
Description
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.
Time Frame
2 hours after birth
Title
A maternal information form
Description
This form consisted of 13 items asking for the participants' sociodemographic characteristics
Time Frame
before birth
Title
Visual Analog Scale for Pain (VASP)
Description
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).
Time Frame
Evaluation was done until delivery (on average between 8-12 hours)
Title
Postpartum Comfort Questionnaire (PPCQ)
Description
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.
Time Frame
2 hours after birth
Title
Evalution labour pain
Description
VASP was evaluated before and after acupressure and shower applications.
Time Frame
Evaluation was done until delivery (on average between 8-12 hours)
Title
Evalution postpartum comfort
Description
Postpartum Comfort levels were evaluated in the postpartum period.
Time Frame
2 hours after birth
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYCA SOLT KIRCA, Phd
Organizational Affiliation
Kırklareli University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DERYA KANZA GÜL, Md, Phd
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medipol University
City
Istanbul
ZIP/Postal Code
34180
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Delivery Pain and Postpartum Comfort
We'll reach out to this number within 24 hrs