The Door to the Womb at Birth: Haptonomy

August 26, 2024 updated by: Burcu KUCUKKAYA, Trakya University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Bartin, Turkey, 78100
        • Bartın University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No action will be taken. Surveys and scales will be applied.
Experimental: Haptonomy
  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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version
Time Frame: 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.
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
Time Frame: 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 - 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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-SBB-0594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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