Clinical trial NCT05386004: Labour Pain and Birth-Specific Stereogram Cards (BSSC)
Official title: Effects Of Focus On Birth-Specific Stereogram Cards (BSSC) On Perception Of Labour Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Birth, First
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Introduction Labour pain is not only sensory, but a multifaceted subjective phenomenon having emotional, motivational and cognitive dimensions .The American Academy of Obstetrics and Gynecology (ACOG) and the Society of Anesthesiology (ASA) report that labour pain should be remedied by a therapy due to the maternal and fetal effects of the severe labour pain. In the management of labour pain, non-pharmacological approaches are aiming to increase maternal satisfaction, control feeling in birth and sufficiency sense, and to reduce obstetric interventions. Distraction and cognitive strategies are used to prevent the transmission of painful stimuli information to the central nervous system. In painful situations, pain transmission is prevented by distracting the attention from pain ensuring focus stimuli other pain in transmission by focusing on stimuli outside the pain.

Distraction during delivery includes the process of removing a woman's attention from the pain of birth by means of any external stimuli. Especially, determination of a focal spot enables to maintain the concentration. Images can be the focus of any object. It is seen that the "plippets" cards known as the "distraction cards" and virtual realityare used in reducing the perceived pain level. However, there was no study showing the effect of "focus and distraction" on the perceived labour pain. The stereoscopic vision technique discovered by Charles Wheatstone in 1838 is also based on focus. Stereogram is the general name of two-dimensional (2D) images that create three-dimensional (3D) perception in the mind. A person can focus the lenses on the stereograms of the lenses, zoom the eyeballs to a distant point located behind the stereogram image and thus trick the brain and allow the brain view the 3D images.The stereograms known as "squint at and be surprised" in Turkey in the 90s were popular in the "magic eye" series especially in the USA .

There are different methods to view the targeted three-dimensional image in the stereogram. Some people may see the images simply in a stereogram, while others have to educate their eyes to separate the eye convergence resulting from the focus of the lens. One of the methods that may be used is to hold the image against face so that the nose contacts with the image. Most people cannot focus on the image, while the image is too close to their eyes. If the person moves the image away from his/her face slowly, the brain will focus on pairs of patterns that correspond to the degree of convergence of the two eyeballs at one point. Another method is to look constantly at an object behind the image to obtain the suitable degree of convergence while keeping the field of view constant on the image for purpose of convincing the brain to focus on the image. In a modified method, the person constantly looks at his/her own reflection on the bright surface. Thus, it shall be ensured that the brain achieves the necessary degree of convergence when focus on the near field, and that the three-dimensional image behind the pattern is visible.

On the basis of the stereoscopic vision technique, it is thought that focusing on the stereogram cards specially prepared for birth can also be effective in reducing the labour pain perception. In this study, researchers aim to determine the effect of focusing on birth-specific stereogram cards(BSSC) on labour pain perception.

Methods Study design This research is an experimental prospective randomized controlled clinical study.

Sample and Setting The research was conducted at the delivery room of a state hospital in Istanbul. In the delivery room where the work was conducted, 528 nulliparous women gave the vaginal birth. At the time of the research the standard midwifery care provided in the hospital during birth.

60 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 test group (BSSC group) and 30 ones were in the control group. Power analysis is performed in the PASS program to determine the number of samples of the study.

According to previous studies, it is assumed that the difference between the level of pain between the experimental (BSSC) group and the control group is 5 after the intervention and the standard deviation of the control and the experimental group at the first measurement is 2. It is determined that, when the significance level α = 0.05 is taken as the power of 1-β = 0.99, the sample size is 30 for the control group and 30 for the experimental group. The research findings are limited to the research sample, can not be generalized.

İnterventions The pregnant women, who agreed the study, were included in randomization. All applicant is given a barcode number in the polyclinic. This barcode number was used for randomization. Single numbers were included in the experimental group, double in the numbers control group. The participants in the BSSC group were given a practical training on the focus technique on stereogram cards for one hour in the prenatal final trimester. The participants in the BSSC group were admitted to the delivery room when the birth process started. It was ensured that the participants in the BSSC group were focus on contractions in the latent phase, active phase and the transition phase by BSSC throughout. The participants in the BSSC group were admitted a pain assessment via VAS every two hours before and after the focus in parallel with clinical routine practice. A VAS was administered to the delivery room in the first admission and every two hours after birth without any interference to the participant in the control group. The state anxiety scale was assessed to both groups when cervical dilatation was 3-4 cm in the latent phase and cervical dilatation was 8-9 cm in the transition phase. Postpartum fatigue level and satisfaction of participants from birth were applied to both groups at the 2nd hour postpartum.

Data Collection The Pregnancy Data Form, State Anxiety Scale, BSSC, VAS, Postpartum Data Form were used as data collection tools.

The Pregnancy Data Form was prepared based on the literature. It consists of questions about the socio-demographic characteristics, medical and obstetric characteristics of the pregnant wo man, information and thoughts about the current pregnancy and birth.

Intrapartum Process Data Form includes about Gestational week, date and time of birth pain, drugs and applications in the first stage of labour, table before and after the application of stereogram card (cervical dilatation and wiping, level of head and condition of membranes, severity and frequency of contractions, fetal heart rate ( FKA), the mother's vital signs and behaviors during labour), the time when the second stage begins, the end time, the total duration of labour.

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.

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.

Postpartum evaluation data form was prepared to evaluate the birth process for the participants of BSSC group and control group. At the end of the 2nd hour, the pregnant woman's thoughts about this birth, her thoughts about the labour pain, how she felt at the end of the birth and her satisfaction with the practices performed during the labour are included.

Design of BSSC The structure of the stereograms consists of two images. One of them is a depth map and the other is a texture map. These two visual elements are combined with specially designed computer software. Birth-specific stereogram cards (BSSC) in birth are designed by researchers and are created using the stereogram creator program. In the BSSC design, it was used as a tissue image to attract the attention of the mothers, and the pregnant, father, baby silhouettes were used as oxytocic pictures. These three-dimensional visual images were revised and finalized in the pilot study. BSSC is designed as a set with images to facilitate the use of the mothers. BSSC's 10 cards set with different patterns and silhouettes on the background.

Ethical Considerations Pregnant Women have given their written informed consent. The study protocol has been approved by the ethical committee of the Şişli Hamidiye Etfal Education and Research Hospital, Study No: 569 on the 27th October 2015.

Data Analysis The analysis were performed, using SPSS software version 20 (Statistical Package for Social Sciences Inc, IL, USA).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.).

Primary outcomes:
measure: Durations of stage of labour in Birth- Specific Stereogram Cards (BSSC) group and control group
timeFrame: during the first stage of birth (up to 12 hours)
measure: Comparison of Visual Analog Scale (VAS) score averages of the Birth- Specific Stereogram Cards (BSSC) group and control group
timeFrame: every two hours during the first stage of labor (during the first stage of birth (up to 12 hours)
measure: Comparison of state anxiety and postpartum fatigue levels of the Birth- Specific Stereogram Cards(BSSC) group and control group
timeFrame: 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:
measure: Evaluation of the opinions of the BSSC group participants about the BSSC application
timeFrame: 2 hours after birth (up to 2 hours)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Atlas University
state: İ̇stanbul
Study officials:
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