The Effect of Haptonomy Applied to Pregnant Women

First Pregnancy Clinical Trial

Official title:

The Effect of Haptonomy Applied to Pregnant Women on Perceived Stress, Fear of Childbirth and Prenatal Attachment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240092
• Other study ID #: TR SIVAS02
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: February 2022
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• First Pregnancy

Intervention

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

Locations

Country	Name	City	State
Turkey	Sukran Ertekin Pinar	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View 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. — View Citation

Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. — View Citation

Veringa IK, de Bruin EI, Bardacke N, Duncan LG, van Steensel FJ, Dirksen CD, Bögels 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Week 7
Other	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.	Week 7
Other	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.	Week 7
Primary	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
Primary	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
Primary	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	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.	Week 3
Secondary	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.	Week 3
Secondary	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.	Week 3

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