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

NCT05494840 | Completed

• 1 other identifier: TR TOKAT01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

First Pregnancy

Keywords

haptonomy; distress; psychological well-being; anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (3)

• Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)

  Week 3

• Tilburg Pregnancy Distress Scale (TPDS)

  Week 3

• Psychological well-being scale

  Week 3

Other Outcomes (3)

• Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)

  Week 6

• Tilburg Pregnancy Distress Scale (TPDS)

  Week 6

• Psychological well-being scale

  Week 6

Study Arms (3)

Haptonomy- first experimental Group

EXPERIMENTAL

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).

Behavioral: Haptonomy

Haptonomy- second experimental Group

EXPERIMENTAL

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).

Behavioral: Haptonomy

Haptonomy- Control Group

NO INTERVENTION

Standard of care Group The control group will not be interfered with.

Interventions

Haptonomy BEHAVIORAL

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

Haptonomy- first experimental Group; Haptonomy- second experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multiparity

Sponsors & Collaborators

• Hilal Özbek: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (21)

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

  BACKGROUND

• 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.

  PMID: 29655006 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25912270 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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].

  BACKGROUND

• 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.

  PMID: 33229283 BACKGROUND

• 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.

  PMID: 32169030 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Rathfisch, Gulay. (2019). Prenatal haptonomy course notes [PowerPoint slide]. İstanbul.

  BACKGROUND

• Simsek Kucukkelepce, D., Aydin Ozkan, S., & Yilmaz, S. (2022). Investigation of the relationship between postpartum depression in primiparous pregnants experiencing psychological distress during pregnancy: Prospective study. Journal of Social and Analytical Health, 2(1), 8-14. https://doi.org/10.5281/ZENODO.6342685

  BACKGROUND

• Telef, B. B. (2011). The Adaptation of Psychological Well-Being into Turkish: A Validity and Reliability Study. XI. Psychological Counseling and Guidance Congress.

  BACKGROUND

• Telef, B. B. (2013). The Adaptation of Psychological Well-Being into Turkish: A Validity and Reliability Study. HU Journal of Education, 28(3), 374-384.

  BACKGROUND

• Veldman F. Philosophy behind science. Confirming affectivity, the dawn of human life: the pre-, peri- and postnatal affective-confirming. Haptonomic accompaniment of parents and their child. Neuro Endocrinol Lett. 2001 Aug;22(4):295-304.

  PMID: 11524636 BACKGROUND

• Yan H, Ding Y, Guo W. Mental Health of Pregnant and Postpartum Women During the Coronavirus Disease 2019 Pandemic: A Systematic Review and Meta-Analysis. Front Psychol. 2020 Nov 25;11:617001. doi: 10.3389/fpsyg.2020.617001. eCollection 2020.

  PMID: 33324308 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Study Officials

• Hilal Özbek

  Tokat Gaziosmanpaşa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: September 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)