Multımedia Information Before Amniocentesıs And Chorion Villus Sampling
NCT Number: NCT06572436
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amniocentesis|Chorionic Villus Sampling
Interventions: BEHAVIORAL: Multimedia information training
Sponsor: Akdeniz University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10-20
Completion Date: 2025-04-01

Summary:
It is known that the anxiety levels of pregnant women are high before amniocentesis and chorionic villus sampling and it is often neglected. The aim of this study is to examine the effects of multimedia information given before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety, pain, stress and fear levels of pregnant women.

Pregnant women who are planned to undergo amniocentesis and chorionic villus sampling are included in this prospective randomized controlled study. 90 pregnant women are randomized into two groups as study (n=45) and control group (n=45). Pregnant women in the study group are educated with multimedia information before amniocentesis and chorionic villus sampling. Pregnant women in the control group are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling. Anxiety, pain, stress and fear levels are assessed immediately before multimedia information and after amniocentesis and chorionic villus sampling.

Primary Outcome Measures: Change of Anxiety Score, State-Trait Anxiety Inventory-I and II (STAI-I-II) is used to measure temporary and permanent anxiety.. These scales are four-point Likert type consisting of 20 items. While the STAI-I describes an individual's feelings at a specific moment or under specific conditions, STAI-II describes how an individual feels regardless of the situation and conditions. The scale includes direct and indirect (reverse) statements. The total scores of the indirect (reverse) statements are subtracted from the total weighted scores obtained from the direct statements and a fixed value of 50 points is added for STAI-I and 35 points for STAI-II.

After being included in the study, the initial anxiety levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second anxiety levels of the participants in both groups are assessed., Change from Baseline Anxiety Score through study completion, an average of 1 hour|Change of Pain Score, The Visual Analog Scale (VAS) was used as a one-dimensional scale for pain assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of pain. Always "0" means no pain, while "10" means excruciating pain.

When asked, patients touch a point corresponding to their degree of pain, and this mark indicates the degree of pain on the scale. Higher scores indicate greater pain severity.

After being included in the study, the initial pain levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second pain levels of the participants in both groups are assessed., Change from Baseline Pain Score through study completion, an average of 1 hour|Change of Fear Score, The Visual Analog Scale (VAS) was used as a one-dimensional scale for fear assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of fear. Always "0" means no pain, while "10" means excruciating fear.

When asked, patients touch a point corresponding to their degree of fear, and this mark indicates the degree of fear on the scale. Higher scores indicate greater fear severity.

After being included in the study, the initial fear levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second fear levels of the participants in both groups are assessed., Change from Baseline Fear Score through study completion, an average of 1 hour|Change of Stress Score, The Visual Analog Scale (VAS) was used as a one-dimensional scale for stress assessment. VAS is a self-administered, one-dimensional measure of stress intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of stress. Always "0" means no pain, while "10" means excruciating stress.

When asked, patients touch a point corresponding to their degree of stress, and this mark indicates the degree of stress on the scale. Higher scores indicate greater stress severity.

After being included in the study, the initial stress levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second stress levels of the participants in both groups are assessed., Change from Baseline Stress Score through study completion, an average of 1 hour
Secondary Outcome Measures: Height in Meters, The height of all subjects in meters (m) will be noted before the surgery., Initial assessment before amniocentesis and chorionic villus sampling .|Weight in Kilograms, The weight of all subjects in kilograms (kg) will be noted before the surgery., Initial assessment before amniocentesis and chorionic villus sampling .|Body Mass Index (BMI) in kg/m^2, Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)\^2., Initial assessment before amniocentesis and chorionic villus sampling .