Clinical trial NCT05494840: The Effect of Prenatal Haptonomy on Anxiety, Distress and Psychological Well-being
Official title: The Effect of Prenatal Haptonomy on Pregnancy-related Anxiety, Distress and Psychological Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Pregnancy
Keywords: haptonomy
distress
psychological well-being
anxiety
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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 22-27 weeks of gestation,
* without perception and communication problems,
* and who agreed to participate in the study were included in the study.

Exclusion Criteria:

• Multiparity

Primary outcomes:
measure: Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)
timeFrame: Baseline
measure: Tilburg Pregnancy Distress Scale (TPDS)
timeFrame: Baseline
measure: Psychological well-being scale
timeFrame: Baseline
Secondary outcomes:
measure: Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)
timeFrame: Week 3
measure: Tilburg Pregnancy Distress Scale (TPDS)
timeFrame: Week 3
measure: Psychological well-being scale
timeFrame: Week 3
Other outcomes:
measure: Pregnancy-Related Anxiety Questionnaire-Revised-2 (PRAQ-R2)
timeFrame: Week 6
measure: Tilburg Pregnancy Distress Scale (TPDS)
timeFrame: Week 6
measure: Psychological well-being scale
timeFrame: Week 6
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
affiliation: Tokat Gaziosmanpaşa University
name: Hilal Özbek
role: PRINCIPAL_INVESTIGATOR
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