NCT06508554

Brief Summary

Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor. Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 13, 2024

Last Update Submit

August 26, 2024

Conditions

Keywords

HaptonomyBirth Expectation

Outcome Measures

Primary Outcomes (3)

  • Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version

    This scale was adapted from Wijma et al. Developed by. The purpose of the scale is to evaluate women's fear of birth during their own birth experiences in the postpartum period. Turkish validity and reliability study was conducted by Uçar and Beji. The scale consists of 33 items. Each item is a 6-point Likert type with scores ranging from 1 to 6, with 1 being "completely" and 6 being "not at all". While the minimum score on the scale is 33, the maximum score is 198. High scores indicate that women have a high fear of childbirth. Negatively loaded questions in the scale (2, 3, 6, 7, 8, 11, 12,15, 19, 20, 24, 25, 27, 31) are calculated by reversing them in the opposite direction to ensure consistency in measurement.

    change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

  • Self-Efficacy Scale in Labor

    Self-Efficacy Scale in Labor - Short Version' was developed by Ip et al. to measure self-efficacy levels in labor. The Turkish validity and reliability study of the scale was conducted by Ersoy (2011). The scale consists of two sub-dimensions: outcome expectation and competence expectation, and there are 16 questions in each sub-dimension. The lowest score to be obtained from the sub-dimensions of the scale is 16 and the highest score is 160. A high score from each subscale indicates that pregnant women have high expectations of adequacy and outcome regarding labor. Responses on a Likert-type scale are scored from 1 to 10.

    change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

  • Birth Memory and Recall Scale

    This scale developed by Foley et al. in 2014, was adapted into Turkish by Topkara and Çağan in 2021. The scale is a 7-point Likert type. The scale, which consists of a total of 21 items, has six sub-dimensions. Its sub-dimensions are "Emotional Memory", "Ambivalent Emotional Memory", "Centeredness of Memory", "Coherence and Reliving", "Sensory Memory" and "Involuntary Remembering". The highest score that can be obtained from the scale is 147 and the lowest score is 6. High scores from the "Emotional Memory" sub-dimension indicate that the mother's negative emotions about the birth experience are more intense, high scores from the "Ambivalent Emotional Memory" sub-dimension indicate that the mother has more ambivalent emotions, and high scores from the "Centeredness of Memory" sub-dimension indicate that the mother has more ambivalent emotions.

    change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

Study Arms (2)

Control

NO INTERVENTION

No action will be taken. Surveys and scales will be applied.

Haptonomy

EXPERIMENTAL

1. A face-to-face sitting position will be taken for the application. 2. Throughout the research, the study will be accompanied by the music desired by each pregnant woman. The same music chosen by the woman or couple will be used throughout the work. 3. The application will be done with the pregnant woman's eyes closed. 4. The application will start with breathing exercises and the body will be relaxed with the help of abdominal and chest breathing (hara breathing). 5. With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. The researcher and the pregnant woman will place their left hands on each other's hearts. The aim is to feel the energy flowing from each other, to feel the heart, to open the third eye and to prepare the hands. This study aims to increase the pregnant woman's confidence in her own emotions and body by getting to know her emotions and body.

Other: Haptonomy

Interventions

5\. With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. It will be ensured that the mother's communication with her baby has a spiritual dimension as well as a physical one. 6. Then the stage of touching and communicating with the baby will begin. The hands of the researcher and the pregnant woman will be placed on the pregnant woman's uterus. Then, the pregnant woman will be the first to call her baby. This call to the baby will be repeated 2-3 times. 7. The pregnant woman and her uterus will be touched and exercises will be performed to adapt to the fetus. The aim is to increase the emotional awareness of the pregnant woman and to enable her to play intrauterine games with her baby (such as calling the baby, shaking her belly, moving the baby to the touched area with the mother's voice). Haptonomy will be completed with a deep relaxation exercise that will support the heart-uterus connection accompanied by breathing exercises.

Haptonomy

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Married and pregnant women,
  • ≥ 18 years old,
  • Able to read, write and understand Turkish,
  • Living in the city center where the study is conducted,
  • Does not have any physical or psychological health problems for herself or her baby,
  • Having a spontaneous pregnancy at 28.\< gestational weeks,
  • Those who have not received haptonomy application before,
  • Pregnant women who agreed to participate in the study were included.

You may not qualify if:

  • Those with psychological and chronic health problems,
  • Pregnant women who did not agree to participate in the study were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, 78100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy ComplicationsMemory Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

July 13, 2024

First Posted

July 18, 2024

Study Start

October 10, 2023

Primary Completion

February 25, 2024

Study Completion

August 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations