AzTrials
AzTrials

Labor PainNCT05386004

Labour Pain and Birth-Specific Stereogram Cards (BSSC)

A study testing Birth-Specific Stereogram Cards (BSSC) in people with Labor Pain and Birth, First, run by Atlas University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Birth, First
What is being tested?
Birth-Specific Stereogram Cards (BSSC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2015to 27 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Contractions have started and are regular
  • No language problem
  • Verbal communication
  • Pregnant women accepted to study.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İstanbul Atlas University

    Istanbul, İ̇stanbul, 34406

Other trials in Turkey (Türkiye)

About this study

Official title: Effects Of Focus On Birth-Specific Stereogram Cards (BSSC) On Perception Of Labour Pain

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.

Read more

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.

Read the 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).

Being tested
Birth-Specific Stereogram Cards (BSSC)
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Birth-Specific Stereogram Cards (BSSC)Other

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

Study groups in NCT05386004
Study groupRoleWhat they receive
BSSC groupExperimentalParticipants in the experimental group were allowed to focus with BSSC during uterine contractions in the first stage of labor.
Receives: Other: Birth-Specific Stereogram Cards (BSSC)
control groupNo interventionThe participants in the control group were provided with routine care in the first stage of labor. No intervention was made.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

    Measured: 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)
  1. Evaluation of the opinions of the BSSC group participants about the BSSC application

    Application of a questionnaire consisting of questions measuring BSSC group participants' satisfaction with the BSSC application, whether they find the application effective, and whether they want to use BSSC in their next birth.

    Measured: 2 hours after birth (up to 2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start1 Nov 2015
  3. Primary completion27 Dec 2017
  4. Study completion27 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386004
Sponsor's protocol ID
interventional
Status last verified
May 2022
First submitted
14 Apr 2022
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data on the study will be published and shared in a journal.

Publications

  • American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG committee opinion. No. 339: Analgesia and cesarean delivery rates. Obstet Gynecol. 2006 Jun;107(6):1487-8. doi: 10.1097/00006250-200606000-00060.

    PubMed 16738188
  • Alp, N., Mete, S. (2008). Effect of Postpartum Fatigue Level, Sleep and Nutrition on Fatigue. The Journalof the Nursing School, Ataturk University, 11(4).

  • Altunoglu, S. (2017) Stereogram types and structures. Access: 10.01.2017. https://www.academia.edu/16704677/

  • ASA. (2010). American Society of Anesthesia. Committee of Origin: Obstetrical Anesthesia (Approved by the ASA House of Delegates on October 13, 1999 and last amended on October 20. 2010.

  • Beevi Z, Low WY, Hassan J. The Effectiveness of Hypnosis Intervention for Labor: An Experimental Study. Am J Clin Hypn. 2017 Oct;60(2):172-191. doi: 10.1080/00029157.2017.1280659.

    PubMed 28891771
  • Boaviagem A, Melo Junior E, Lubambo L, Sousa P, Aragao C, Albuquerque S, Lemos A. The effectiveness of breathing patterns to control maternal anxiety during the first period of labor: A randomized controlled clinical trial. Complement Ther Clin Pract. 2017 Feb;26:30-35. doi: 10.1016/j.ctcp.2016.11.004. Epub 2016 Nov 11.

    PubMed 28107846
  • Canbulat N, Inal S, Sonmezer H. Efficacy of distraction methods on procedural pain and anxiety by applying distraction cards and kaleidoscope in children. Asian Nurs Res (Korean Soc Nurs Sci). 2014 Mar;8(1):23-8. doi: 10.1016/j.anr.2013.12.001. Epub 2013 Dec 14.

    PubMed 25030489
  • Chaillet N, Belaid L, Crochetiere C, Roy L, Gagne GP, Moutquin JM, Rossignol M, Dugas M, Wassef M, Bonapace J. Nonpharmacologic approaches for pain management during labor compared with usual care: a meta-analysis. Birth. 2014 Jun;41(2):122-37. doi: 10.1111/birt.12103. Epub 2014 Apr 25.

    PubMed 24761801
  • Choudhury N, Amer I, Daniels M, Wareing MJ. Audiovisual distraction reduces pain perception during aural microsuction. Ann R Coll Surg Engl. 2013 Jan;95(1):34-6. doi: 10.1308/003588413X13511609955535.

    PubMed 23317724
  • Creehan, P.A. (2007). Pain Relief and Comfort Measure in Labour. In: Kathleen Rice Simpson, Patricia A. Creehan (3rd Ed).Awhonn's Perinatal Nursing;: 333-460p.

  • Fahami F, Behmanesh F, Valiani M, Ashouri E. Effect of heat therapy on pain severity in primigravida women. Iran J Nurs Midwifery Res. 2011 Winter;16(1):113-6.

    PubMed 22039388
  • Finlayson K, Downe S, Hinder S, Carr H, Spiby H, Whorwell P. Unexpected consequences: women's experiences of a self-hypnosis intervention to help with pain relief during labour. BMC Pregnancy Childbirth. 2015 Sep 25;15:229. doi: 10.1186/s12884-015-0659-0.

    PubMed 26407981
  • Floris L, Irion O, Courvoisier D. Influence of obstetrical events on satisfaction and anxiety during childbirth: a prospective longitudinal study. Psychol Health Med. 2017 Sep;22(8):969-977. doi: 10.1080/13548506.2016.1258480. Epub 2016 Nov 17.

    PubMed 27855515
  • Gantz L, Bedell HE. Transfer of perceptual learning of depth discrimination between local and global stereograms. Vision Res. 2010 Aug 23;50(18):1891-9. doi: 10.1016/j.visres.2010.06.011. Epub 2010 Jun 25.

    PubMed 20600234
  • Gomez AT, Lupon N, Cardona G, Aznar-Casanova JA. Visual mechanisms governing the perception of auto-stereograms. Clin Exp Optom. 2012 Mar;95(2):146-52. doi: 10.1111/j.1444-0938.2011.00664.x. Epub 2011 Oct 24.

    PubMed 22023025

Questions about this trial

What is this clinical trial studying?

A study testing Birth-Specific Stereogram Cards (BSSC) in people with Labor Pain and Birth, First, run by Atlas University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durations of stage of labour in Birth- Specific Stereogram Cards (BSSC) group and control group (time frame: during the first stage of birth (up to 12 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386004, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in