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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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First Pregnancy

Intervention / Treatment
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* Behavioral: Haptonomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haptonomy- first experimental Group<br>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<br>* Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.<br>|
| Experimental: Haptonomy- second experimental Group<br>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<br>* Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.<br>|
| No Intervention: Haptonomy- Control Group<br>Standard of care Group The control group will not be interfered with. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 3 | 
| 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. | Week 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. | Week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haptonomy, distress, psychological well-being, anxiety