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Completed

NCT Number: NCT05240092

The Effect of Haptonomy Applied to Pregnant Women

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).

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Key information

Conditions

First Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sukran Ertekin Pinar

Sivas, 58140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haptonomy

Behavioral

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

Other names: Control Group

Primary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

  3. Prenatal Attachment Inventory (PAI)

    Time frame: Baseline

    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.

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: Week 3

    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.

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

    Time frame: Week 3

    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.

  3. Prenatal Attachment Inventory (PAI)

    Time frame: Week 3

    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.

Other outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: Week 7

    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.

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

    Time frame: Week 7

    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.

  3. Prenatal Attachment Inventory (PAI)

    Time frame: Week 7

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2022
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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