NCT05969535

Brief Summary

Communication between nurse and patient is considered essential to provide holistic and humane care as it allows patients to be fully understood, assisted, and their needs defined as empathetic. Travelbee, states that nursing is conducted through human-to-human relationships. These relationships begin first with the encounter of the nurse and the patient, then with the stage of emergence of identities where the relationship begins, the stage in which the nurse and the patient perceive each other's uniqueness, the empathy stage in which the person shares their experiences, the sympathy stage in which the nurse wants to reduce the cause of the patient's pain, and the final stage is the nurse and the patient's interrelated thoughts and feelings, their interest and concern towards others, a non-judgmental attitude and a person specific to each individual it consists of the stage of harmony that he approaches with respect. During this biological process, many physiological and psychological changes can be expected in pregnant women. Many psychological and social factors influence the fear of childbirth. These factors include; Lack of self-confidence in childbirth, being affected by negative birth histories, history of depression, anxiety, partner dissatisfaction, young maternal age, low income level, low education and low perception of social support, pain in childbirth or fear of losing control, and physical injury during childbirth. It is also possible that the fear of childbirth and the appearance of symptoms of stress and anxiety, which complicates pregnancy. Mother-infant bonding, which is adversely affected by mental problems such as anxiety, depression and fear of childbirth during pregnancy, can adversely affect the attachment process in both prenatal period. There are some non-pharmaceutical applications to strengthen the mental health of the mother, to reduce stress and fear of childbirth, and to strengthen the mother-baby bond. These are practices that include listening to music, psychoeducation, cognitive and behavioral therapies. With professional support in this study, childbirth will take place in a completely safe environment where stress and fear of childbirth are less. Nurses need to communicate from person to person in order to achieve the goal of effective care and to be healing. The training program was created based on Travelbee's five-step human-to-human relationship model with pregnant women who fear childbirth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 3, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

July 12, 2023

Last Update Submit

October 9, 2023

Conditions

Keywords

fear of childbirthprenatal attachmentanxietypregnancyhuman to human relationship

Outcome Measures

Primary Outcomes (3)

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

    It is a scale developed to determine the birth fear and stress of pregnant women. W-DEQ version A is a 6-point Likert-type scale consisting of 33 items. While the minimum score on the scale is 0, the maximum score is 165. The negatively charged questions (2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31) in the scale are calculated by reversing them. A high score indicates a high level of fear of childbirth. The cutoff point is 85. A score of 85 and above indicates clinical fear of childbirth. The Cronbach's Alpha value of the scale was found to be 0.88 for primiparous pregnants and 0.90 for multiparous pregnants. * 0-37 points = mild fear of childbirth * 38-65 points = moderate fear of childbirth * 66-84 points = severe fear of childbirth * 85 and above = clinical fear of childbirth

    each participant pregnant will be evaluated for outcome measure for four weeks

  • Beck Anxiety Scale (BAI)

    It is a scale developed to measure anxiety symptoms and reveal the cognitive aspects of anxiety. The scale consists of 21 items and is a four-point Likert type scale scored between 0-3. The lowest 0 and the highest 63 points are obtained in the scale. For each item, it is required to tick one of the options "None", "Mild", "Moderate", "Severe". 13 items evaluate physiological symptoms, 5 items describe the cognitive aspect, 3 items represent both somatic and cognitive symptoms. The high total score obtained in the scale indicates the severity of the anxiety experienced by the individual. The Cronbach alpha value of the scale was found to be 0.93.

    each participant pregnant will be evaluated for outcome measure for four weeks

  • Prenatal Attachment Inventory (PAI)

    Prenatal attachment inventory was developed to explain the thoughts, feelings and experiences of pregnant women and to determine mother-baby attachment levels. The scale is applied to pregnant women in the 20th and 40th weeks of pregnancy. The scale consists of 21 items. A minimum of 21 points and a maximum of 84 points can be obtained from the scale. An increase in the score indicates that the level of attachment to the baby also increases. The Cronbach Alpha reliability coefficient of the scale was stated as 0.84.

    each participant pregnant will be evaluated for outcome measure for four weeks

Study Arms (2)

intervention group

EXPERIMENTAL

This group will consist of 35 primiparous pregnant women. The training program, prepared in line with travelbe's human-human relations model, will continue for a total of 4 weeks, 2 days a week.

Behavioral: Birth preparation education according to travelbee human-human relations theory

control group

NO INTERVENTION

This group will consist of 35 primiparous pregnant women. No training program will be given to this group and routine pregnant follow-up will continue.

Interventions

human-to-human communication and psychoeducation-assisted birth preparation training

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince there is a training program on pregnant women, female gender was preferred.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and over.
  • At least primary school graduate.
  • According to the last menstrual period or for pregnant women who do not know the last menstruation date, to be between 20-34 weeks in the calculations made with USG data.
  • Intermediate and higher score on the Wijma birth expectancy/experience scale version A.
  • Having a single and live pregnancy.
  • Having your first pregnancy.
  • Agreeing to participate in the research.
  • Having trouble communicating.
  • No infertility treatment.
  • No contraindications for vaginal delivery

You may not qualify if:

  • Pregnant women with medical indications.
  • Those with high-risk pregnancies.
  • Having given birth before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat City Hospital

Yozgat, 66000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Tuğba Sarı, Nurse

    Yozgat City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: According to the WIJMA version A scale, two groups will be formed by randomization method as intervention and control group for pregnant women who are determined to have fear of middle and higher birth. 8 sessions of psychoeducation program will be given to the pregnant women in the intervention group. The control group will continue routine monitoring. After the training, the level of fear of birth, prenatal attachment and anxiety levels will be compared between the two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 1, 2023

Study Start

July 3, 2023

Primary Completion

September 11, 2023

Study Completion

September 21, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

All IPD collected and affecting the outcome of the study will be published

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting 6 months after publication
Access Criteria
Only the collected data will be shared for analysis.

Locations