NCT05240092

Brief Summary

Introduction: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process. This study was conducted to determine the effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment. Methods: The population of the randomized controlled experimental study consisted of 72 primiparous pregnant women within the gestational weeks 22-28 who presented to the Obstetrics and Gynecology Polyclinic of a state hospital in Turkey for check-up (36 experimental subjects, 36 control subjects).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

September 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

December 20, 2021

Last Update Submit

February 10, 2022

Conditions

Keywords

Fear of ChildbirthHaptonomyPerceived StressPrenatal Attachment

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale (PSS)

    The PSS is a validated, The scale consists of 10 items, each item receives 1,2,3,4,5 points in turn and is evaluated over total score. Total score ranges from 10-50, and an increase in the score indicates an increase in perceived stress level.

    Baseline

  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

    The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.

    Baseline

  • Prenatal Attachment Inventory (PAI)

    The PSS is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period. Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increase in the score obtained by pregnant indicates that level of attachment also increases.

    Baseline

Secondary Outcomes (3)

  • Perceived Stress Scale (PSS)

    Week 3

  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

    Week 3

  • Prenatal Attachment Inventory (PAI)

    Week 3

Other Outcomes (3)

  • Perceived Stress Scale (PSS)

    Week 7

  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

    Week 7

  • Prenatal Attachment Inventory (PAI)

    Week 7

Study Arms (2)

Haptonomy Group

EXPERIMENTAL

A home visit was made to the experimental group, and haptonomy was applied for at least 30 minutes, once a week, for 7 weeks (with the researcher for 3 weeks, with the husband by providing the training brochure and video that will help the practice for the next 4 weeks).

Behavioral: Haptonomy

Standard of care Group

NO INTERVENTION

The control group did not receive any treatment.

Interventions

HaptonomyBEHAVIORAL

Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.

Also known as: Control Group
Haptonomy Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous pregnant women who were married,
  • aged 18 years and over,
  • literate,
  • living in the city center,
  • not having any health problems in themselves and their infants,
  • with spontaneous pregnancy at 22-28 weeks of gestation,
  • without perception and communication problems,
  • and who agreed to participate in the study were included in the study.

You may not qualify if:

  • Multiparity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sukran Ertekin Pinar

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (4)

  • Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.

    PMID: 22260727BACKGROUND
  • Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. doi: 10.1177/019394599301500205. No abstract available.

    PMID: 8470375BACKGROUND
  • Veringa IK, de Bruin EI, Bardacke N, Duncan LG, van Steensel FJ, Dirksen CD, Bogels SM. 'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial. BMC Psychiatry. 2016 Nov 7;16(1):377. doi: 10.1186/s12888-016-1070-8.

    PMID: 27821151BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sükran Ertekin Pinar

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr

Study Record Dates

First Submitted

December 20, 2021

First Posted

February 15, 2022

Study Start

September 10, 2020

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations