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First PregnancyNCT05494840

The Effect of Prenatal Haptonomy on Anxiety, Distress and Psychological Well-being

A study testing Haptonomy in people with First Pregnancy, run by Hilal Özbek 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:Anksiyete experienced during prenatal can increase Distress, cause negative perinatal outcomes, and adversely affect the psychological well-being. This study will conducted to determine the effect of prenatal haptonomy on pregnancy-related anxiety, distress and psychological well-being. 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
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2022to 30 Dec 2023
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 22-27 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

  • Tokat Gaziosmanpasa University

    Tokat Province, 60250

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Prenatal Haptonomy on Pregnancy-related Anxiety, Distress and Psychological Well-being

Introduction:Anksiyete experienced during prenatal can increase Distress, cause negative perinatal outcomes, and adversely affect the psychological well-being. This study will conducted to determine the effect of prenatal haptonomy on pregnancy-related anxiety, distress and psychological well-being.

Methods: The population of the randomized controlled experimental study will consist of 102 primiparous pregnant women within the gestational weeks 22-27 who presented to the pregnant school of a state hospital in Turkey (34 first experimental group, 34 second experimental group, 34 control group).

Read the detailed description

Background: Anksiyete experienced during prenatal can increase Distress, cause negative perinatal outcomes, and adversely affect the psychological well-being.

Aim: This study will conducted to determine the effect of prenatal haptonomy on pregnancy-related anxiety, distress and psychological well-being.

Metod: For the educational study of the research, the midwife working in the Pregnant Class will be interviewed and informed about it. The mat and seat cushions in the Pregnant Class will be arranged by the researcher in a way that is suitable for the application. Music will be played during the application. Wellness music recommended by the haptonomy trainer will be selected for the music (Rathfisch, 2019). Haptonomy application is planned to be performed individually with pregnant women. Pregnant women in the experimental group 1 and 2 will be given the haptonomy application together with the trainings (standard care practices) in the pregnant class, and the pregnant women in the control group will only be trained in the pregnant class. Pregnant class trainings include reproductive health physiology, problems that can be seen in pregnancy, birth process, newborn care, covering the prenatal period, birth and postpartum period.

Haptonomy- first experimental Group: Haptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 6 weeks (with the researcher).

Haptonomy- second experimental Group: Haptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 3 weeks (with the researcher).

Haptonomy- Control Group: Standard of care Group The control group will not be interfered with.

Conditions
First Pregnancy
Being tested
Haptonomy
Keywords
haptonomy, distress, psychological well-being, anxiety
Medical subject headings
Psychological Well-Being, Anxiety Disorders

What participants receive

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

  • HaptonomyBehavioural

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

Study groups in NCT05494840
Study groupRoleWhat they receive
Haptonomy- first experimental GroupExperimentalHaptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 6 weeks (with the researcher).
Receives: Behavioral: Haptonomy
Haptonomy- second experimental GroupExperimentalHaptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 3 weeks (with the researcher).
Receives: Behavioral: Haptonomy
Haptonomy- Control GroupNo interventionStandard of care Group The control group will not be interfered with.

What is being measured

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

  1. Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)

    This scale consisting of 10 items is a 5-point Likert-type scale to question women's pregnancy-related anxiety levels. The scale items are scored between 1 and 5 (1-Absolutely not relevant and 5-Very relevant). The lowest and highest scores are 11 and 55 for primiparous women, and 10 and 50 for multiparous women, respectively. A higher scale score indicates a higher level of anxiety in pregnancy.

    Measured: Baseline

  2. Tilburg Pregnancy Distress Scale (TPDS)

    This scale consisting of 16 items is a 4-point Likert-type scale. The scale items are scored between 0 and 3 (very often 0 points, quite often 1 point, occasionally 2 points, rarely/never 3 points). A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress.

    Measured: Baseline

  3. Psychological well-being scale

    This scale consisting of 8 items is a 7-point Likert-type scale. The scale items are scored between 1 and 7 (1-Absolutely not relevant and 7-Very relevant). The lowest and highest scores are 8 and 56 respectively. A high score indicates that the person has many psychological resources and strengths.

    Measured: Baseline

Secondary outcomes (3)

  1. Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)

    This scale consisting of 10 items is a 5-point Likert-type scale to question women's pregnancy-related anxiety levels. The scale items are scored between 1 and 5 (1-Absolutely not relevant and 5-Very relevant). The lowest and highest scores are 11 and 55 for primiparous women, and 10 and 50 for multiparous women, respectively. A higher scale score indicates a higher level of anxiety in pregnancy.

    Measured: Week 3

  2. Tilburg Pregnancy Distress Scale (TPDS)

    This scale consisting of 16 items is a 4-point Likert-type scale. The scale items are scored between 0 and 3 (very often 0 points, quite often 1 point, occasionally 2 points, rarely/never 3 points). A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress.

    Measured: Week 3

  3. Psychological well-being scale

    This scale consisting of 8 items is a 7-point Likert-type scale. The scale items are scored between 1 and 7 (1-Absolutely not relevant and 7-Very relevant). The lowest and highest scores are 8 and 56 respectively. A high score indicates that the person has many psychological resources and strengths.

    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 posted10 Aug 2022
  2. Study start15 Sep 2022
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

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
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05494840
Sponsor's protocol ID
TR TOKAT01
Status last verified
Jan 2024
First submitted
8 Aug 2022
Last updated
8 Jan 2024
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

  • Adam, E. M. (2012). L ' haptonomie Un projetpourunenaissance [Un projetpourunenaissance]. Université Henri Poincaré, Nancy I.

  • Aksoy Derya Y, Timur Tashan S, Duman M, Durgun Ozan Y. Turkish adaptation of the pregnancy-related anxiety questionnaire-revised 2: Validity and reliability study in multiparous and primiparous pregnancy. Midwifery. 2018 Jul;62:61-68. doi: 10.1016/j.midw.2018.03.006. Epub 2018 Mar 27.

    PubMed 29655006

  • Arabin, B., & Metz, G. A. S. (2020). Environmental enrichment and pregnancy: Paradigms of (epi)genetic effects of social or sensory stimulation. Gynakologe, 53(7), 433-443. https://doi.org/10.1007/s00129-020-04622-2

  • Bilgen, O., & Tekim, U. (2020). Marriage Satisfaction In Thelast Three Months Of Pregnancy The Effect On Depression. USBED, 2(2), 138153.

  • Capik A, Pasinlioglu T. Validity and reliability study of the Tilburg Pregnancy Distress Scale into Turkish. J Psychiatr Ment Health Nurs. 2015 May;22(4):260-9. doi: 10.1111/jpm.12211.

    PubMed 25912270

  • Célestin-Lhopiteau, I., & Wanquet-Thibault, P. (2018). Haptonomie. In Guide des pratiques psychocorporelles: 25 techniques (relaxation, hypnoseart-thérapie, toucher, etc.) (2nd ed., pp. 186-190). Elsevier Health Sciences.

  • Çiltaş, N. Y., & Köse Tuncer, S. (2019). Gebelikte Distresin Tanımlanması: Erzincan Örneği. Mehmet Akif Ersoy Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 7(1), 15-24. https://doi.org/10.24998/maeusabed.518546

  • CIRDH. (2018). Haptonomie pré et postnatale. International Center for Research and Development of Haptonomy. https://www.haptonomie.org/fr/espace-public/accompagnement-haptonomique-pre-et-postnatal.html

  • Dufay, L. (2019). École de Psychologues Praticiens [Mémoire De Recherche en vue de l'obtention du Diplôme De Psychologue, École de Psychologues Pratıcıens Instıtut Catholıque de Parıs].

  • Duman M, Durgun Ozan Y, Aksoy Derya Y, Timur Tashan S. The effect of relaxation exercises training on pregnancy-related anxiety after perinatal loss: A pilot randomized control trial✰. Explore (NY). 2022 Jan-Feb;18(1):44-50. doi: 10.1016/j.explore.2020.11.002. Epub 2020 Nov 17.

    PubMed 33229283

  • Hulsbosch LP, Nyklicek I, Potharst ES, Meems M, Boekhorst MGBM, Pop VJM. Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial. BMC Pregnancy Childbirth. 2020 Mar 13;20(1):159. doi: 10.1186/s12884-020-2843-0.

    PubMed 32169030

  • Kaya Zaman, F., Ozkan, N., & Toprak, D. (2018). Depression and Anxiety in Pregnancy. Konuralp Medical Journal, 10(1), 20-25. https://doi.org/10.18521/ktd.311793

  • Kilic, A., & Can Gürkan, Ö. (2021). Evidence-Based Use of Music Therapy During Pregnancy, Birth and Postpartum. KTO Karatay University Journal of Health Sciences. 2(1): 47-60.

  • Klabbers, G. A. (2018). Can haptotherapy reduce fear of childbirth? Some first answers from a randomized controlled trial [PhD Thesis]. Tilburg Üniversity.

  • Paica, C. I. (2017). Prenatal and Postnatal Psychological Counselling The conscious assumption of the maternal role. Journal of Experiential Psychotherapy, 20(2), 24-31.

Questions about this trial

What is this clinical trial studying?

A study testing Haptonomy in people with First Pregnancy, run by Hilal Özbek 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 8 Jan 2024. 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?

Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2) (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 NCT05494840, which also lists 21 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 8 Jan 2024.

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