Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-29 @ 3:05 AM
Study NCT ID:
NCT05778435
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2022-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Wireless Fetal Monitoring System on Comfort, Pain and Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childbirth Comfort Questionnaire', 'timeFrame': 'When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.', 'description': 'The participants rated the questionnaire through a Likert-type scale ranging from 1 to 5. The scores that can be obtained from the scale vary from 9 to 45. Higher scores indicate higher comfort during labor, whereas lower scores mean lower comfort'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the VAS were filled out by the researcher between contractions, when the pregnant feels good.', 'description': 'To measure the level of the pain, mostly a 10-cm-long vertical or horizontal line labeled from "No pain" to "Unbearable pain" is used. The participants are asked to mark their pain level on the line by a line, dot, or simply showing. The distance between the "no pain" point and the marked point indicates the level of pain'}, {'measure': 'Birth Satisfaction Scale-Revised', 'timeFrame': 'The BSS-R was conducted 1 h after the mother was taken from the labor room to the gynecology and obstetrics service. The time required for the rest need of the postpartum mother, to meet her personal needs and breastfeed her baby was also provided', 'description': 'The lowest and the highest scores that can be obtained from the scale were 0 and 40, respectively. Higher scores indicate higher satisfaction. Satisfaction is classified as low satisfaction (0-13), medium satisfaction (14-27), and high satisfaction (28-40). The scale is implemented within the first three days after delivery birth.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Birth', 'Chilbirth Satisfaction', 'Wireless Fetal Monitoring', 'Comfort'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '32019499', 'type': 'BACKGROUND', 'citation': "van den Heuvel JFM, Teunis CJ, Franx A, Crombag NMTH, Bekker MN. Home-based telemonitoring versus hospital admission in high risk pregnancies: a qualitative study on women's experiences. BMC Pregnancy Childbirth. 2020 Feb 4;20(1):77. doi: 10.1186/s12884-020-2779-4."}, {'type': 'BACKGROUND', 'citation': 'Menihan CA, Kopel E. Electronic Fetal Monitoring: Concepts and Applications. 2nd Ed. Chapter 2. Philadelphia, Lippincott: Williams&Wilkins; 2008.'}, {'pmid': '32087146', 'type': 'BACKGROUND', 'citation': 'Monson M, Heuser C, Einerson BD, Esplin I, Snow G, Varner M, Esplin MS. Evaluation of an external fetal electrocardiogram monitoring system: a randomized controlled trial. Am J Obstet Gynecol. 2020 Aug;223(2):244.e1-244.e12. doi: 10.1016/j.ajog.2020.02.012. Epub 2020 Feb 20.'}, {'pmid': '25874722', 'type': 'BACKGROUND', 'citation': 'Alfirevic Z, Stampalija T, Medley N. Fetal and umbilical Doppler ultrasound in normal pregnancy. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD001450. doi: 10.1002/14651858.CD001450.pub4.'}, {'pmid': '28595604', 'type': 'BACKGROUND', 'citation': 'Mugyenyi GR, Atukunda EC, Ngonzi J, Boatin A, Wylie BJ, Haberer JE. Functionality and acceptability of a wireless fetal heart rate monitoring device in term pregnant women in rural Southwestern Uganda. BMC Pregnancy Childbirth. 2017 Jun 8;17(1):178. doi: 10.1186/s12884-017-1361-1.'}, {'pmid': '31662396', 'type': 'BACKGROUND', 'citation': 'van den Heuvel JFM, Ganzevoort W, De Haan-Jebbink JM, van der Ham DP, Deurloo KL, Seeber L, Franx A, Bekker MN. HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial. BMJ Open. 2019 Oct 28;9(10):e031700. doi: 10.1136/bmjopen-2019-031700.'}, {'pmid': '33345967', 'type': 'BACKGROUND', 'citation': 'Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.'}, {'pmid': '22537349', 'type': 'BACKGROUND', 'citation': "Rubarth LB, Schoening AM, Cosimano A, Sandhurst H. Women's experience of hospitalized bed rest during high-risk pregnancy. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):398-407. doi: 10.1111/j.1552-6909.2012.01349.x. Epub 2012 Apr 26."}, {'pmid': '25193792', 'type': 'BACKGROUND', 'citation': 'Kent RA, Yazbek M, Heyns T, Coetzee I. The support needs of high-risk antenatal patients in prolonged hospitalisation. Midwifery. 2015 Jan;31(1):164-9. doi: 10.1016/j.midw.2014.08.003. Epub 2014 Aug 15.'}, {'pmid': '24105444', 'type': 'BACKGROUND', 'citation': 'Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Oct 9;2013(10):CD003934. doi: 10.1002/14651858.CD003934.pub4.'}, {'pmid': '30441327', 'type': 'BACKGROUND', 'citation': 'Nguyen K, Bamgbose E, Cox BP, Huang SP, Mierzwa A, Hutchins S, Caso B, Culjat M, Connelly C, Lacoursiere DY, Singh RS. Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4397-4400. doi: 10.1109/EMBC.2018.8513321.'}, {'pmid': '29553295', 'type': 'BACKGROUND', 'citation': 'Goncu Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19.'}, {'pmid': '33972445', 'type': 'BACKGROUND', 'citation': 'Ryu D, Kim DH, Price JT, Lee JY, Chung HU, Allen E, Walter JR, Jeong H, Cao J, Kulikova E, Abu-Zayed H, Lee R, Martell KL, Zhang M, Kampmeier BR, Hill M, Lee J, Kim E, Park Y, Jang H, Arafa H, Liu C, Chisembele M, Vwalika B, Sindano N, Spelke MB, Paller AS, Premkumar A, Grobman WA, Stringer JSA, Rogers JA, Xu S. Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2100466118. doi: 10.1073/pnas.2100466118.'}, {'pmid': '17695343', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.'}, {'pmid': '16856111', 'type': 'BACKGROUND', 'citation': 'Alfirevic Z, Devane D, Gyte GM. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD006066. doi: 10.1002/14651858.CD006066.'}, {'type': 'BACKGROUND', 'citation': "Delice K. Before Birth Of Pregnant, Memoır, Postpartum Evaluation Of Knowledge Level Of Satisfaction From Services (Elbistan Sample). Master's thesis, Beykent University, Social Sciences Institute, Department Of Business, Hospıtal And Health Institutions Management Department, Istanbul. 2019. https://tez.yok.gov.tr/UlusalTezMerkezi/tezDetay.jsp?id=1gk8TzmGFaXVQPYkrUU_4Q&no=Enb8wsxJlkjAQuCt4e2yfQ"}, {'type': 'BACKGROUND', 'citation': 'Coskuner Potur D, Dogan Merih Y. The Validity and Reliability of the Turkish Version of the Childbirth Comfort Questionnaire. Journal of Anatolia Nursing and Health Sciences. 2015;18(4):252-258.'}, {'pmid': '4139420', 'type': 'BACKGROUND', 'citation': 'Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.'}, {'pmid': '21456488', 'type': 'BACKGROUND', 'citation': 'Martin CH, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 2011;24(2):124-35. doi: 10.1108/09526861111105086.'}, {'type': 'BACKGROUND', 'citation': 'Roham M, Saldivar E, Raghavan S, Zurcher M, Mack J, Mehregany M. A mobile wearable wireless fetal heart monitoring system. In 2011 5th International Symposium on Medical Information and Communication Technology (pp. 135-138). IEEE. (2011, March).'}, {'type': 'BACKGROUND', 'citation': 'Akbas P, Ozkan Sat S, Is M, Yaman S. Turkısh Validity-Reliability Study Of The Scale Of For Coping With Labor Pain. Journal of Health Sciences of Kocaeli University. 2021;7(3):235-241.'}, {'type': 'BACKGROUND', 'citation': 'Pehlivan N, Demirel Bozkurt O. Vertıcal position in the second stage of labor: Vertical birth chair. Acta Medica Nicomedia. 2020;3(1):42-48.'}, {'pmid': '30264201', 'type': 'BACKGROUND', 'citation': 'Schramm K, Lapert F, Nees J, Lempersz C, Oei SG, Haun MW, Maatouk I, Bruckner T, Sohn C, Schott S. Acceptance of a new non-invasive fetal monitoring system and attitude for telemedicine approaches in obstetrics: a case-control study. Arch Gynecol Obstet. 2018 Dec;298(6):1085-1093. doi: 10.1007/s00404-018-4918-y. Epub 2018 Sep 27.'}, {'pmid': '30070803', 'type': 'BACKGROUND', 'citation': 'WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/'}, {'type': 'BACKGROUND', 'citation': 'Essa MR, Hafez SK. Effect of different positions of pregnant women on their comfort and fetal cardiotocographic patterns during nonstress test. International Journal For Research in Health Sciences And Nursing. 2018;4(2):1-24.'}, {'pmid': '34219033', 'type': 'BACKGROUND', 'citation': 'Watson K, Mills TA, Lavender T. Experiences and outcomes on the use of telemetry to monitor the fetal heart during labour: findings from a mixed methods study. Women Birth. 2022 May;35(3):e243-e252. doi: 10.1016/j.wombi.2021.06.004. Epub 2021 Jul 2.'}, {'type': 'BACKGROUND', 'citation': 'Harkey KT, Casale MB, Pantelopoulos AA, Zurcher MA. Assessing the clinical use of a novel, mobile fetal monitoring device. Obstetrics & Gynecology. 2014;123:55S.'}, {'pmid': '25622043', 'type': 'RESULT', 'citation': 'Boatin AA, Wylie B, Goldfarb I, Azevedo R, Pittel E, Ng C, Haberer J. Wireless fetal heart rate monitoring in inpatient full-term pregnant women: testing functionality and acceptability. PLoS One. 2015 Jan 26;10(1):e0117043. doi: 10.1371/journal.pone.0117043. eCollection 2015.'}, {'pmid': '32299728', 'type': 'RESULT', 'citation': 'Knupp RJ, Andrews WW, Tita ATN. The future of electronic fetal monitoring. Best Pract Res Clin Obstet Gynaecol. 2020 Aug;67:44-52. doi: 10.1016/j.bpobgyn.2020.02.004. Epub 2020 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Wireless EFM shortens labor duration, increases birth satisfaction, and reduces perceived pain during labor. With wireless EFM, comfort in labor increases and higher labor comfort increases birth satisfaction. As perceived pain in labor decreases, birth satisfaction increases. Therefore, wireless EFM practice is recommended during the antepartum and intrapartum periods.', 'detailedDescription': "Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction.\n\nBackground While EFM is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country.\n\nAim This randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction.\n\nMethods The study population consisted of 88 women, divided into two groups the experimental group (n=44) and the control group (n=44). The data were collected with the Personal Information Form, Childbirth Comfort Questionnaire (CCQ), Visual Pain Scale (VAS), and Birth Satisfaction Scale-Revised (BSS-R). During the intrapartum period, the wireless fetal monitoring system was used in the experimental group and the wired fetal monitoring system was used in the control group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who are willing to participate in the study,\n* Aged 18-40 years,\n* Having a healthy pregnancy,\n* With a gestational age of \\> 37+0 weeks,\n* With a cervical dilatation of 4-5 cm,\n* With a singleton pregnancy,\n* With a live fetus,\n* Can speak Turkish,\n* Do not have comprehension, perception, and communication problems participated in the study.\n\nExclusion Criteria:\n\n* Pregnant women who did not comply with the study had communication problems,\n* Had complications,\n* Needed urgent cesarean delivery and wanted to withdraw from the study were excluded from the study'}, 'identificationModule': {'nctId': 'NCT05778435', 'briefTitle': 'The Effect of Wireless Fetal Monitoring System on Comfort, Pain and Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': "The Effect Of The Wireless Fetal Monitoring Used During Birth On The Women's Comfort, Labour Pain And Birth Satisfaction", 'orgStudyIdInfo': {'id': 'TRTOKAT60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wireless fetal monitoring group', 'description': 'wireless fetal monitoring system was applied to the experimental group', 'interventionNames': ['Device: wireless fetal monitoring system']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard wired fetal monitoring system was applied to the control group.'}], 'interventions': [{'name': 'wireless fetal monitoring system', 'type': 'DEVICE', 'description': 'The wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.', 'armGroupLabels': ['wireless fetal monitoring group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Gülseren Dağlar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}, {'name': 'Demet Çakır', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist.Prof.Dr.', 'investigatorFullName': 'Demet Cakir', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}