NCT04820296

Brief Summary

This study was planned as a randomized controlled experimental study with posttest and control group in order to evaluate the effect of the solution focused approach method applied to primigravidas on psychosocial health, fear of childbirth and postnatal security sensations

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 23, 2021

Last Update Submit

April 24, 2023

Conditions

Keywords

Solution-oriented approachFear of childbirthPsychosocial healthmothersFeelings of securityPregnancy

Outcome Measures

Primary Outcomes (4)

  • Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

    It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

    First assessment will be made at the baseline (pre-intervention).

  • Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

    It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

    The second assessment will take place 4 weeks after the first assessment (after the program is completed).

  • Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

    It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

    Third assessment will take place average 3 weeks after the second assessment.

  • Wijma Birth Expectancy / Experience Scale (W-DEQ) Version B

    W-DEQ version B was developed by Klaas and Barbro Wijma (1998) to measure the experiences of women with fear of childbirth in the postpartum period. Körükcü et al. (2014), the scale, which was adapted to Turkish and valid and reliable, consists of 32 items and six sub-dimensions. The sub-dimensions of the scale are, respectively, anxiety about labor pain, inadequacy of positive behavior, loneliness, inadequate positive emotions, anxiety about delivery, and anxiety about the baby. Answers in the scale are scored between 0 and 5. While the minimum score in the scale is 0, the maximum score is 160. As the score increases, the fear of childbirth that women experience increases.

    The W-DEQ scale version B (only posttest) will be administered within the first 24 hours of postpartum.

Secondary Outcomes (4)

  • Psychosocial Health Assessment Scale During Pregnancy

    First assessment will be made at the baseline (pre-intervention).

  • Psychosocial Health Assessment Scale During Pregnancy

    The second assessment will take place 4 weeks after the first assessment (after the program is completed).

  • Psychosocial Health Assessment Scale During Pregnancy

    Third assessment will take place average 3 weeks after the second assessment.

  • Mother's Postnatal Senses of Security Scale

    At the end of the 7th postpartum day, follow-up counseling will be provided by telephone and the Postpartum Sense of Security Scale (posttest only) will be filled.

Study Arms (2)

Experimental group

EXPERIMENTAL

Pregnant women in the experimental group will be given 4 sessions Solution-Oriented Approach program, starting at the 32th week of pregnancy. Pregnants in the experimental group will be administered the Wijma Birth Expectation/Experience Scale (W-DEQ-A) and Pregnancy Psychosocial Health Assessment Scale (PPHAS) before the intervention. After the program is completed, a training booklet will be provided for pregnant women and (W-DEQ-A) and PPHAS will be applied again. With pregnant women, 37-40. between gestational weeks, they will be contacted again, face-to-face interview method (W-DEQ-A) and PPHAS again will be evaluated. The pregnant women will inform the researcher by phone after the delivery and the researcher will visit the hospital within the first 24 hours after the delivery to evaluate the mothers' birth fear levels Scale (W-DEQ-B). At the end of the first postpartum week, the postnatal senses of security of the mothers will be evaluated by telephone follow-up counseling.

Other: Solution-Oriented Approach

Control group

NO INTERVENTION

Pregnant women in the control group will only receive routine care. Pregnant women in the control group will be administered the same scales simultaneously with the experimental group.

Interventions

First Session: Sharing thoughts about perception of childbirth, Creating positive goals, Informing about Birth, Birth Process, Basic Breathing Exercises and Deep Relaxation Exercises, Homework Second Session: Evaluating homework, Sharing thoughts about fear of childbirth, Miracle Question Technique, Evaluating with the Rating Questions Technique, Reframing the problem, Briefing on 'Body-Mind Connection at Birth, Fear-Tension-Pain Cycle, Hormones of Birth' and Breathing exercises, Homework Third session: Evaluating homework, Sharing thoughts about positive birth story, Information on symptoms indicating that the childbirth is approaching, pushing techniques, delivery positions, endorphin massage and breathing exercises (4/8 breaths, full breath when baby moves), Homework Fourth Session: Evaluating homework, Mother Baby Friendly Caesarean and Breathing exercises (3 candles a feather breath), Sharing feelings about the counseling process

Experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least primary education graduate
  • Speaking and understanding Turkish
  • Pregnant women between the ages of 18-35
  • Residing at the provincial border of Konya
  • Primigravidas
  • Women who got pregnant without treatment pregnancy,
  • Have no barriers to vaginal birth,
  • Pregnant women who are at the 32nd gestational week according to their last menstrual week
  • Pregnant women with a single and healthy fetus

You may not qualify if:

  • Pregnant women with any risky pregnancy history (Placenta previa, preeclampsia, oligohydramnios and polyhydramnios, gestational diabetes etc.),
  • Pregnant women with any systemic and neurological disease,
  • Pregnant women with chronic and/or psychiatric health problems (based on self-report and clinical diagnosis),
  • Pregnant women with cesarean indication,
  • Pregnant women participating in any birth preparation training program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, 42080, Turkey (Türkiye)

Location

Study Officials

  • YEŞİM ANIK, MSc

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • KAMİLE ALTUNTUĞ, PhD

    Necmettin Erbakan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Posttest and control grouped randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 29, 2021

Study Start

September 20, 2021

Primary Completion

May 27, 2022

Study Completion

March 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Study Protocol

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be published in a peer-reviewed journal within 6 months.
Access Criteria
After the study protocol is published, the name and link of the journal in which the publication was published will be shared.

Locations