Multımedia Information Before Amniocentesıs And Chorion Villus Sampling

NCT06572436 | Not Yet Recruiting

• 1 other identifier: Akdenizpregnant
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Amniocentesis; Chorionic Villus Sampling

Keywords

amniocentesis; anxiety; chorionic villus sampling; fear; multimedia information; pain; pregnant; stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Height in Meters

  Initial assessment before amniocentesis and chorionic villus sampling .

• Weight in Kilograms

  Initial assessment before amniocentesis and chorionic villus sampling .

• Body Mass Index (BMI) in kg/m^2

  Initial assessment before amniocentesis and chorionic villus sampling .

Study Arms (2)

Control Group

NO INTERVENTION

Pregnant women in the control group were not given multimedia information before amniocentesis and chorionic villus sampling, but were given brief verbal information about the procedure before amniocentesis and chorionic villus sampling.

Multimedia information group

EXPERIMENTAL

Pregnant women in the study group were given multimedia information by watching a short video before amniocentesis and chorionic villus sampling. The multimedia information training consisted of a 5-minute video containing detailed amniocentesis and chorionic villus sampling application information. A 5-minute video was developed by the authors and used for research purposes only. The video was designed to provide pregnant women with a comprehensive overview of the amniocentesis and chorionic villus sampling procedure, its benefits, and potential risks, and included real-life images to depict all aspects of the procedure.

Behavioral: Multimedia information training

Interventions

Multimedia information training BEHAVIORAL

The multimedia information training consisted of a 5-minute video containing detailed amniocentesis and chorionic villus sampling application information. A 5-minute video was developed by the authors and used for research purposes only. The video was designed to provide pregnant women with a comprehensive overview of the amniocentesis and chorionic villus sampling procedure, its benefits, and potential risks, and included real-life images to depict all aspects of the procedure.

Multimedia information group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women;
• who were scheduled to undergo amniocentesis and chorionic villus sampling by the responsible physician who applied to University Hospital Gynecology and Obstetrics Clinic,
• who did not have known cerebrovascular disease
• who did not have morbid obesity or heart disease that would prevent the study
• who did not have cognitive disorders that would prevent communication
• who did not have a history of stroke or related effects, and who agreed to participate in the study.

You may not qualify if:

• Pregnant women who had previously undergone amniocentesis and chorionic villus sampling and who did not agree to participate in the study

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neriman Temel Aksu

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neriman Temel Aksu, Dr.

CONTACT

5052973906; nerimantemelaksu@akdeniz.edu.tr

Neriman Temel Aksu, Dr.

CONTACT

nerimantemelaksu@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 27, 2024
• Study Start: October 20, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08