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First PregnancyNCT05240092

The Effect of Haptonomy Applied to Pregnant Women

A study testing Haptonomy in people with First Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
First Pregnancy
What is being tested?
Haptonomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2020to 10 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Multiparity

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sukran Ertekin Pinar

    Sivas, 58140

Other trials in Turkey (Türkiye)

About this study

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

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).

Read the 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.

Conditions
First Pregnancy
Being tested
Haptonomy
Keywords
Fear of Childbirth, Haptonomy, Perceived Stress, Prenatal Attachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HaptonomyBehavioural

    Also called Control Group

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

Study groups in NCT05240092
Study groupRoleWhat they receive
Haptonomy GroupExperimentalA 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).
Receives: Behavioral: Haptonomy
Standard of care GroupNo interventionThe control group did not receive any treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Secondary outcomes (3)

  1. 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.

    Measured: Week 3

  2. 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.

    Measured: Week 3

  3. 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.

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start10 Sep 2020
  3. Primary completion10 Jun 2021
  4. Study completion10 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240092
Sponsor's protocol ID
TR SIVAS02
Status last verified
Feb 2022
First submitted
20 Dec 2021
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • 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.

    PubMed 22260727

  • 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.

    PubMed 8470375

  • 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.

    PubMed 27821151

  • 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.

    PubMed 6668417

Questions about this trial

What is this clinical trial studying?

A study testing Haptonomy in people with First Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Scale (PSS) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240092, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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