Labour Pain and Birth-Specific Stereogram Cards (BSSC)

NCT05386004 | Completed

• 1 other identifier: interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Reducing the perception of labour pain is important to reduce the negative consequences of labour pain and to increase women's satisfaction with the birth experience. Two-dimensional (2D) images (Stereogram) that create the three-dimensional (3D) perception in the mind may be effective in reducing the perception of labour pain. Objectives: This study is conducted for purpose of determining the effect of focus on the birth-specific stereogram cards (BSSC), on perception of labour pain. Methods: This research is an experimental prospective randomized controlled clinical study. The research was conducted at the delivery room of a state hospital in Istanbul. Pregnant women, who agreed to participate in the study and met the study criteria, were included in the study, as 30 ones were in the experimental group (BSSC group) and 30 ones were in the control group. The Pregnancy Data Form, State Anxiety Scale, BSSC, • PRS Review Comments Visual Analog Scale(VAS), Postpartum Data Form were used as data collection tools. The BSSC in birth are designed by researchers and are created using the stereogram creator program. BSSC's 10 cards set with different patterns and silhouettes on the background. The analyses were performed, using SPSS software version 20. KEY WORDS: Birth, Labour pain, Birth-specific stereogram cards, Stereogram card, Focus on birth.

Conditions

Labor Pain; Birth, First

Outcome Measures

Primary Outcomes (3)

• Durations of stage of labour in Birth- Specific Stereogram Cards (BSSC) group and control group

  Comparison of latent, active and transitional phase times for the control and intervention groups. Measuring the effect of BSSC in shortening the birth time. It is desirable that the birth durations (latent, active and transitional phase) of the participants in the intervention group were short and meaningful for study

  during the first stage of birth (up to 12 hours)

• Comparison of Visual Analog Scale (VAS) score averages of the Birth- Specific Stereogram Cards (BSSC) group and control group

  Comparison of VAS scores applied every two hours to the BSSC group and control groups during the latent active and transitional phases in the first stage of labour. VAS is a scale used to measure perceived pain. It was used in the studies to evaluate the perceived birth pain. It was found to be valid and reliable. In the form of a 0-10cm ruler, one end of the scale indicates 0 painlessness and the other 10 indicates the most severe degree of pain intensity.

  every two hours during the first stage of labor (during the first stage of birth (up to 12 hours)

• Comparison of state anxiety and postpartum fatigue levels of the Birth- Specific Stereogram Cards(BSSC) group and control group

  Comparison of The State Anxiety Scale scores applied to the Birth- Specific Stereogram Cards (BSSC) group and control groups in the latent and transitional phases in the first stage of labour. A high state anxiety scale score indicates a high level of anxiety, and a low score indicates a low level of anxiety. State Anxiety Scale was used to measure the level of anxiety experienced by pregnant women in both groups in the first stage of labour. According to the severity of the individual's emotions or behaviors in the situation he / she is experiencing, (1) None, (2) Some, (3) Many and (4) Completely requires to answer by marking one of the options. The state anxiety scale consists of 20 statements. The score obtained from the scale can vary between 20 and 80. The larger the score, the higher the anxiety level, the smaller the lower the level of anxiety.

  in the latent phases (an average of 1 hour after birth) transitional phases (an average of 9 hour after birth) in the first stage of labor.

Secondary Outcomes (1)

• Evaluation of the opinions of the BSSC group participants about the BSSC application

  2 hours after birth (up to 2 hours)

Study Arms (2)

BSSC group

EXPERIMENTAL

Participants in the experimental group were allowed to focus with BSSC during uterine contractions in the first stage of labor.

Other: Birth-Specific Stereogram Cards (BSSC)

control group

NO INTERVENTION

The participants in the control group were provided with routine care in the first stage of labor. No intervention was made.

Interventions

Birth-Specific Stereogram Cards (BSSC) OTHER

Focus on Birth-Specific Stereogram Cards (BSSC) during uterine contractions in latent active and transitional phase

BSSC group

Eligibility Criteria

• Gender Eligibility Details: pregnant women who have started labor
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy in term (37-42W)
• Have a fetus in a single, live and vertex position
• Latent stage of labour
• Cervical dilatation less than 5 cm
• Vaginal delivery planning
• No pregnancy complications
• Contractions have started and are regular
• No language problem
• Verbal communication
• Pregnant women accepted to study.

You may not qualify if:

• Narcotic analgesic or sedative area
• Systemic disease such as heart disease, hypertension, diabetes, kidney disease
• Pregnant women with pregnancy complications (plascenta previa, preeclampsia, oligohydroamnios, polyhydroamnios, position / presentation disorder, etc.).

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

İstanbul Atlas University

Istanbul, İ̇stanbul, 34406, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: Two groups of primiparous pregnant women who met the inclusion criteria and agreed to participate in the study were included in the study. Pregnant women were randomly assigned to experimental and control groups. The experimental group was treated with BSSC.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 23, 2022
• Study Start: November 1, 2015
• Primary Completion: December 27, 2017
• Study Completion: December 27, 2017
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)