- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299136
Evaluating the Effect of Hugging and Praying on Traumatic Birth Perception, Birth Pain, and Birth Anxiety
Study Overview
Status
Intervention / Treatment
Detailed Description
Pregnant women participating in our study will receive the intervention (hugging, praying, and hugging + praying) from the researcher or a relative as often as they wish during labor and contractions. These sessions will be administered during each stage of labor, taking into account when the pregnant woman is ready to begin the intervention.
For the hugging group, hugging sessions will be performed whenever the pregnant woman wants and during contractions, if she wishes, by a relative (husband, mother, sister, etc.) or midwife. The pregnant woman can be hugged for as long as she wants or for 5-10 minutes. For the prayer group, whenever the pregnant woman wishes, or during contractions if she wishes, a close relative (husband, mother, sister, etc.) or midwife will recite a prayer chosen by the pregnant woman, if she has one; if she does not have a preferred prayer, the first 5 verses of Surah Al-Inshiqaq will be recited:
In the name of Allah, the Most Gracious, the Most Merciful
- When the sky is split asunder,
- And obeys the command of its Lord,
- When the earth is stretched out flat,
- And casts forth what is within it,
- And obeys the command of its Lord, every person will be confronted with what they have done! To be read together Before starting the first session, the "Information Form," "Visual Analog Scale," Traumatic Birth Perception Scale, and "Oxford Birth Anxiety Scale (Appendix 4)" will be administered. and at the end of the first, second, and fourth stages of birth, the "Visual Analog Scale," "Traumatic Birth Perception Scale," and "Oxford Birth Anxiety Scale" will be administered.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ağrı
-
Ağrı, Ağrı, Turkey (Türkiye), 04100
- Ağri İbrahim Çeçen Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age ≥18 years
- No communication barriers
- Applying to Ağrı Training and Research Hospital for normal delivery within the study dates
- Volunteering to participate in the study
- No contraindications for normal vaginal delivery (e.g., cephalopelvic disproportion)
- Being at term (38-42 weeks)
- No condition preventing praying and hugging
Exclusion Criteria:
- Refusal to participate in the study
- Maternal disease (heart disease, diabetes, etc.)
- Having a preterm or postterm pregnancy
- Undergoing an emergency cesarean section during follow-up
- Having a fetal malformation (anencephaly, Down syndrome, etc.)
- Not answering the questions in the questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Hugging
|
For the hugging group, hugging sessions will be provided whenever the pregnant woman desires and during contractions, if she wishes, by a close relative (husband, mother, sister, etc.) or midwife.
The pregnant woman can be hugged for as long as she wants or for 5-10 minutes.
|
|
Experimental: Group 2
Praying
|
For the prayer group, whenever the pregnant woman wishes, or during contractions if she wishes, a close relative (husband, mother, sister, etc.) or midwife will recite a prayer of the pregnant woman's choice, if she has one; if she does not have a preferred prayer, the first 5 verses of Surah Al-Inshiqaq will be recited: In the name of Allah, the Most Gracious, the Most Merciful
|
|
Experimental: Group 3
Hugging and Praying
|
The Hugging and Praying group will perform both hugging and praying together with the woman.
|
|
No Intervention: Group 4
CONTROL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Information Form
Time Frame: Before starting the first session average 8 months
|
This form, prepared by the researcher in line with the literature, inquires about the socio-demographic characteristics of the participants.
|
Before starting the first session average 8 months
|
|
Visual Analog Scale (VAS)
Time Frame: average 8 months
|
It is a one-dimensional scale that objectively assesses a pregnant woman's perception of pain.
It allows some values that cannot be measured numerically to be converted into numerical values.
In 1921, Hayes and Peterson argued that emotional levels could be expressed on lines.
The VAS was first developed and used by Bond and Pilowsky in 1966.
The VAS is a 100 mm (10 cm) ruler used to quantitatively determine pain intensity, with one end representing painlessness (0 = no pain) and the other end representing the most severe pain (10 = severe pain).
The patient marks any point between the two points that corresponds to the severity of their pain.
The distance between the end of the scale representing painlessness and the point marked by the patient is measured with a ruler and recorded in centimeters.
This numerical value indicates the pregnant woman's pain intensity.
0 cm = No pain, 0.53 cm = Mild pain, 3.5-6.5 = Moderate (Ergin, 2013; Aslan, 2006; Mucuk, 2009).
|
average 8 months
|
|
Traumatic Birth Perception Scale
Time Frame: average 8 months
|
TThe Traumatic Birth Perception Scale (TBRS), developed by Yalnız et al. in 2016, is a thirteen-item, unidimensional Likert-type separation scale (Yalnız et al., 2016).
Scores range from 0 to 10 for all items not requiring reverse scoring.
The minimum scale score is 0 and the maximum is 130.
The total scale score ranges from 0 to 26, indicating very low levels of perception of traumatic birth; 27 to 52, indicating low levels; 53 to 78, indicating moderate levels; 79 to 104, indicating high levels; and 105 to 130, indicating very high levels of perception of traumatic birth.
The scale's Cronbach's alpha coefficient is .89
(Yalnız et al., 2016).
|
average 8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nurten Özçalkap, Ağri İbrahim Çeçen Universty
- Study Chair: SİBEL YÜCETÜRK, Asist. Prof., SİNOP UNIVERSTY
- Study Director: AYŞE Çuvadar, Assot Prof., KARABUK UNIVERTY
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/38 (Other Identifier: HATAY MUSTAFA KEMAL UNIVERSITY)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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