NCT07299136

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

April 22, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 28, 2025

Last Update Submit

April 18, 2026

Conditions

Keywords

birthhuggingprayingpainanxietytrauma

Outcome Measures

Primary Outcomes (3)

  • Information Form

    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)

    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

    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

Study Arms (4)

Group 1

EXPERIMENTAL

Hugging

Other: Hugging group,

Group 2

EXPERIMENTAL

Praying

Other: Prayer group

Group 3

EXPERIMENTAL

Hugging and Praying

Other: Hugging and Praying group

Group 4

NO INTERVENTION

CONTROL

Interventions

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 1. When the sky is split asunder, 2. And obeys the command of its Lord, 3. When the earth is stretched out flat, 4. And casts forth what is within it, 5. And obeys the command of its Lord, every person will be confronted with what they have done! To be recited together

Group 2

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.

Group 1

The Hugging and Praying group will perform both hugging and praying together with the woman.

Group 3

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağri İbrahim Çeçen Universty

Ağrı, Ağrı, 04100, Turkey (Türkiye)

Location

Related Publications (1)

  • Redshaw M, Martin C, Rowe R, Hockley C. The Oxford Worries about Labour Scale: women's experience and measurement characteristics of a measure of maternal concern about labour and birth. Psychol Health Med. 2009 May;14(3):354-66. doi: 10.1080/13548500802707159.

MeSH Terms

Conditions

PainAnxiety DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Nurten Özçalkap

    AĞRI İBRAHİM ÇEÇEN UNIVERSTY

    PRINCIPAL INVESTIGATOR
  • SİBEL YÜCETÜRK, Asist. Prof.

    SİNOP UNIVERSTY

    STUDY CHAIR
  • AYŞE Çuvadar, Assot Prof.

    KARABUK UNIVERTY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 23, 2025

Study Start

April 1, 2025

Primary Completion

July 30, 2025

Study Completion

November 30, 2025

Last Updated

April 22, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

we don't share individual participant data with other researchers

Locations