Clinical trial NCT05240092: The Effect of Haptonomy Applied to Pregnant Women
Official title: The Effect of Haptonomy Applied to Pregnant Women on Perceived Stress, Fear of Childbirth and Prenatal Attachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Pregnancy
Keywords: Fear of Childbirth
Haptonomy
Perceived Stress
Prenatal Attachment
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Background: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process.

Aim: 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). 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). The control group did not receive any treatment. Data were collected at the first, third, and seventh weeks using the Pregnancy Description form, the Perceived Stress Scale (PSS), the Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A), and the Prenatal Attachment Inventory (PAI). Number and percentage distribution, chi-square test, t test, Mann-Whitney U test, repeated measures, two-way analysis of variance, Friedman test, and Cohen d test were used in the evaluation of the data.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• Multiparity

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
timeFrame: Baseline
measure: Prenatal Attachment Inventory (PAI)
timeFrame: Baseline
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Week 3
measure: Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
timeFrame: Week 3
measure: Prenatal Attachment Inventory (PAI)
timeFrame: Week 3
Other outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Week 7
measure: Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
timeFrame: Week 7
measure: Prenatal Attachment Inventory (PAI)
timeFrame: Week 7
Locations:
city: Sivas
country: Turkey
facility: Sukran Ertekin Pinar
Study officials:
affiliation: Cumhuriyet University
name: Sükran Ertekin Pinar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.