The Effect of Individual Counselling Program on Fear of Childbirth

NCT04740762 | Completed

• 1 other identifier: Interventional study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

Conditions

Fear of Childbirth; Pregnancy Related

Keywords

Prenatal care; Fear; Childbirth; Counseling; Midwifery

Outcome Measures

Primary Outcomes (10)

• Fear of childbirth before intervention

  assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.

  28-30 gestational weeks

• Fear of childbirth after intervention

  assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.

  36-38 gestational weeks

• Fear of childbirth after birth

  assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6-point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.

  12th-24th hour after the birth

• Childbirth Self-Efficacy before intervention

  assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

  28-30 gestational weeks

• Childbirth Self-Efficacy after intervention

  assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

  36-38 gestational weeks

• State Anxiety before intervention

  assessed using the State Anxiety Inventory. The instrument is composed of 20 items. The total possible score on the instrument varies between 20-80. The measurements according to the State Anxiety Inventory scores indicate no anxiety at a score of 0-19, moderate anxiety at 20-39, a high level of anxiety at 40-59, severe anxiety at 60-79 and panic-evoking anxiety at 80 and above.

  28-30 gestational weeks

• State Anxiety after intervention

  assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

  36-38 gestational weeks

• Duration of labor

  used to determine the duration of labor. Duration of labor was recorded by the researcher to postpartum questionnaire as hours from hospital record.

  12th-24th hour after the birth

• Mode of Delivery

  used to determine the mode of delivery. Mode of delivery was recorded by the researcher to the postpartum questionnaire as vaginal or cesarean section.

  12th-24th hour after the birth

• Elective and Emergency Cesarean Rates

  used to determine the elective and emergency cesarean rates. Elective and emergency cesarean rates were recorded by the researcher to postpartum questionnaires as yes or no from hospital record.

  12th-24th hour after the birth

Secondary Outcomes (4)

• Postpartum hypertension

  12th-24th hour after the birth

• Need for a blood transfusion

  12th-24th hour after the birth

• Admittance of the Newborn into the Intensive Care Unit

  12th-24th hour after the birth

• Preferences for Future Births

  12th-24th hour after the birth

Study Arms (2)

Intervention group

EXPERIMENTAL

The study group were provided with individual counseling program and followed in this study, in addition to the usual care provided by healthcare professionals.

Behavioral: Intervention group

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

Intervention group BEHAVIORAL

The women in the intervention groups were administered a three-session intervention program in addition to the routine care they received.The program encompassed providing the women with an educational booklet, childbirth stories and childbirth videos that were created to reduce their fears of childbirth.The interviews were held a total of three times, in gestational weeks 28-30, 31-33 and 34-36. The duration of the intervention at each visit was 60-80 minutes. Depending on the woman's own preference, she was invited to visit the delivery room at the second or last session and meet the midwives there. The women who did not wish to go to the delivery room were alternatively provided with photographs of the delivery room so they could take a look. Again as part of the education program, the women were given the links to the selected childbirth videos and given the opportunity to watch them.

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparas
• Ages between 18-35
• Lived in Aydın
• In gestational week 28-30,
• Pregnant with a single child
• Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
• In a low-risk pregnancy (on the basis of the criteria of the Ministry of Health),
• Willing to divulge their own or their husband's telephone numbers,

You may not qualify if:

• High-risk pregnancy who had psychological and mental health problems
• History of infertility
• Speech and hearing disabilities
• Substance or narcotics users

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Turkey

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Study Officials

• Gizem Öztürk, PhD

  Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: September 1, 2018
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)