Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT05240092
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Haptonomy Applied to Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'Week 7', 'description': 'The PSS is a validated, The scale consists of 10 items, each item receives 1,2,3,4,5 points in turn and is evaluated over total score. Total score ranges from 10-50, and an increase in the score indicates an increase in perceived stress level.'}, {'measure': 'Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)', 'timeFrame': 'Week 7', 'description': 'The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.'}, {'measure': 'Prenatal Attachment Inventory (PAI)', 'timeFrame': 'Week 7', 'description': 'The PSS is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period. Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increase in the score obtained by pregnant indicates that level of attachment also increases.'}], 'primaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'Baseline', 'description': 'The PSS is a validated, The scale consists of 10 items, each item receives 1,2,3,4,5 points in turn and is evaluated over total score. Total score ranges from 10-50, and an increase in the score indicates an increase in perceived stress level.'}, {'measure': 'Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)', 'timeFrame': 'Baseline', 'description': 'The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.'}, {'measure': 'Prenatal Attachment Inventory (PAI)', 'timeFrame': 'Baseline', 'description': 'The PSS is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period. Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increase in the score obtained by pregnant indicates that level of attachment also increases.'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'Week 3', 'description': 'The PSS is a validated, The scale consists of 10 items, each item receives 1,2,3,4,5 points in turn and is evaluated over total score. Total score ranges from 10-50, and an increase in the score indicates an increase in perceived stress level.'}, {'measure': 'Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)', 'timeFrame': 'Week 3', 'description': 'The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.'}, {'measure': 'Prenatal Attachment Inventory (PAI)', 'timeFrame': 'Week 3', 'description': 'The PSS is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period. Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increase in the score obtained by pregnant indicates that level of attachment also increases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fear of Childbirth', 'Haptonomy', 'Perceived Stress', 'Prenatal Attachment'], 'conditions': ['First Pregnancy']}, 'referencesModule': {'references': [{'pmid': '22260727', 'type': 'BACKGROUND', 'citation': 'Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.'}, {'pmid': '8470375', 'type': 'BACKGROUND', 'citation': 'Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. doi: 10.1177/019394599301500205. No abstract available.'}, {'pmid': '27821151', 'type': 'BACKGROUND', 'citation': "Veringa IK, de Bruin EI, Bardacke N, Duncan LG, van Steensel FJ, Dirksen CD, Bogels SM. 'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial. BMC Psychiatry. 2016 Nov 7;16(1):377. doi: 10.1186/s12888-016-1070-8."}, {'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://hal.univ-lorraine.fr/hal-01875566/document', 'label': "Adam, E. M. (2012). L' haptonomie Un projet pour une naissance. Published online."}, {'url': 'https://doi.org/10.1007/s00129-020-04622-2', 'label': 'Arabin, B., \\& Metz, G. A. S. (2020). Environmental enrichment and pregnancy: paradigms of (epi)genetic effects of social or sensory stimulation. Gynakologe, 53(7), 433-443. https://doi.org/10.1007/s00129-020-04622-2'}, {'url': 'https://doi.org/http://dx.doi.org/10.19082/3733', 'label': 'Arfaie, K., Nahidi, F., Simbar, M., \\& Bakhtiari, M. (2017). The role of fear of childbirth in pregnancy related anxiety in Iranian women: a qualitative research. Electronic Physician, 9(2), 3733-3740. https://doi.org/http://dx.doi.org/10.19082/3733'}, {'url': 'https://doi.org/10.2399/prn.19.0272006', 'label': 'Arslan, A., \\& Temiz, G. (2019). The knowledge, attitude and behavior levels of midwifery students for the non-pharmacological methods used in the management of labor pain. Perinatal Journal, 27(2), 77-88. https://doi.org/10.2399/prn.19.0272006'}, {'url': 'https://www.elsevier-masson.fr/guide-des-pratiques-psychocorporelles-9782294758584.html', 'label': 'Célestin-Lhopiteau, I., \\& Wanquet-Thibault, P. (2018). Haptonomie. In: guide des pratiques psychocorporelles: 25 techniques (relaxation, hypnoseart-thérapie, toucher, etc.) (2nd ed., pp. 186-190). Elsevier Health Sciences.'}, {'url': 'https://haptonomie.org/', 'label': 'CIRDH. (2018a). Haptonomie pré et postnatale. International Center for Research and Development of Haptonomy. Published 2018. Accessed November 18, 2020.'}, {'url': 'https://www.haptonomie.org/en/', 'label': 'CIRDH. (2018b). Presentation of haptonomy: Haptonomy. International center for research and development of haptonomy. Published 2018. Accessed August 28, 2020.'}, {'url': 'https://doi.org/10.1007/s10826-019-01343-6', 'label': 'Dayton, CJ., Brown, S., Goletz, J., Hicks, L., Barron, C., Sperlich, M., \\& Smith-Darden, J. (2019). Pathways to parenting: predictors of prenatal bonding in a sample of expectant mothers and fathers exposed to contextual risk.'}, {'url': 'https://doi.org/10.1016/j.wombi.2018.07.004', 'label': 'Dencker, A., Nilsson, C., Begley, C., Jangsten, E., Mollberg, M., Patel, H., Wigert, H., Hessman, E., Sjöblom, H., \\& Sparud-Lundin, C. (2019). Causes and outcomes in studies of fear of childbirth: a systematic review. Women and Birth, 32(2), 99-111.'}, {'url': 'https://dergipark.org.tr/tr/download/article-file/29648', 'label': 'Dereli Yilmaz, S., \\& Kizilkaya Beji, N. (2013). Prenatal B Turkish version of prenatal attachment inventory: a study of reliability and validity. Journal of Anatolia Nursing and Health Sciensces, 16(2), 103-109.'}, {'url': 'https://doi.org/10.1016/j.spp.2017.11.005', 'label': "Dolto, C. (2018). L'accompagnement pré- et postnatal par l'haptonomie. SoinS Pédiatrie-Puériculture, 39(300), 24-26."}, {'url': 'https://dergipark.org.tr/tr/pub/ataunihem/issue/2632/33865', 'label': 'Erci, B. (2006). Relıabılıty and valıdıty of the turkısh versıon of generalızed perceıved self-effıcacy scale. Ataturk University School of Nursing, 9(1), 58-63.'}, {'url': 'https://doi.org/10.3758/BRM.41.4.1149', 'label': 'Faul, F., Erdfelder, E., Buchner, A., \\& Lang, A.G. (2009). Statistical power analyses using G\\*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41(4), 1149-1160.'}, {'url': 'https://doi.org/10.5772/intechopen.88021', 'label': 'Fernández Fernández-Arroyo, M. (2020). Childbirth Education: Comparative Analysis. In M. Z. Jovandaric \\& S. J. Milenkovic (Eds.), Childbirth (Vol. 32, Issue July, pp. 137-144). IntechOpen.'}, {'url': 'https://doi.org/10.1007/s00737-013-0355-x', 'label': "Hanley, J., Hara, MO., Omay, O., Laure, A., Wisner, K., Coen, A. et. al (2013). The marcé international society international biennial general scientific meeting.Archives of Women's Mental Health, 16(S1), 129"}, {'url': 'https://doi.org/10.1007/s00737-018-0883-5', 'label': "Hermon, N., Wainstock, T., Sheiner, E., Golan, A., \\& Walfisch, A. (2019). Impact of maternal depression on perinatal outcomes in hospitalized women-a prospective study. Archives of Women's Mental Health, 22(1), 85-91."}, {'url': 'http://nopr.niscair.res.in/bitstream/123456789/45060/1/IJTK%2017(4)%20732-740.pdf', 'label': "Hobek Akarsu, R., \\& Rathfisch, G. (2018). The effect of pregnancy yoga on the pregnant's psychosocial health and prenatal attachment. Indian Journal of Traditional Knowledge, 17(4), 732-740."}, {'url': 'https://dergipark.org.tr/tr/pub/gumussagbil/issue/32215/370447', 'label': 'Hobek Akarsu, R., Tuncay, B., \\& Yuzer Alsac, S. (2017). Evidence-based applications in mother-infant attachment. Gumushane University Journal of Health Sciences, 6(4), 275-279.'}, {'url': 'https://doi.org/10.5958/2454-2652.2020.00058.x', 'label': 'Kaur, M. (2020). Evidence-based applications in mother-infant attachment. Gumushane University Journal of Health Sciences, 8(3), 263-267.'}, {'url': 'https://ijhh.org/wp-content/uploads/2019/12/2017-08-10-Han-Kemper-Haptotherapy-and-science.pdf', 'label': 'Kemper, H. C. (2017). Haptotherapy and science Revealing the secret of good research designs and valid measurement methods. International Journal of Haptonomy and Haptotherapy, 10(081708), 10-17.'}, {'url': 'https://pure.uvt.nl/ws/portalfiles/portal/27445680/Klabbers_Can_Haptotherapy_05_09_2018_.pdf', 'label': 'Klabbers, G. A. (2018). Can haptotherapy reduce fear of childbirth? Some first answers from a randomized controlled trial. Tilburg University. Published online. Netherlands.'}, {'url': 'https://research.tilburguniversity.edu/en/publications/does-haptotherapy-benefit-mother-child-bonding-in-women-with-high', 'label': 'Klabbers, G. A., Paarlberg, K. M., \\& Vingerhoets, A. J. J. M. (2018). Does haptotherapy benefit mother-child bonding in women with high fear of childbirth? International Journal of Haptonomy and Haptotherapy, 3(1), 1-7.'}, {'url': 'https://research.tilburguniversity.edu/en/publications/severe-fear-of-childbirth-its-features-assesment-prevalence-deter', 'label': 'Klabbers, G. A., van den Heuvel, M. M. A., van Bakel, H. J. A., \\& Vingerhoets, A. J. J. M. (2016). Severe fear of childbirth: Its features, assesment, prevalence, determinants, consequences and possible treatments. Psychological Topics, 25(1), 107-127.'}, {'url': 'https://doi.org/10.1186/1472-6882-14-385', 'label': 'Klabbers, GA., Wijma, K., Paarlberg, KM., Emons, WHM., \\& Vingerhoets, AJJM. (2014). Treatment of severe fear of childbirth with haptotherapy: Design of a multicenter randomized controlled trial. BMC, 14(1).'}, {'url': 'https://doi.org/10.34087/cbusbed.587467', 'label': 'Koc Ozkan, T., Simsek Kucukkelepce, D., \\& Aydın Ozkan, S. (2020). Relationship between prenatal attachment and body sense in pregnancy and affecting factors. Manisa Celal Bayar University Journal of Institute of Health Science, 7(1), 49-54.'}, {'url': 'https://doi.org/10.1016/j.earlhumdev.2010.09.328', 'label': "Ksycinski, W., Hartman-Ksycinska, A., \\& Pszeniczna, E. (2010). PP-272. Prenatal baby's behaviour with the use of haptonomic techniques and the relevant experiences and reactions of the parents. Early Human Development, 86, S125."}, {'url': 'https://doi.org/10.1016/j.wombi.2017.04.004', 'label': 'Larsson, B., Karlström, A., Rubertsson, C., Ternström, E., Ekdahl, J., Segebladh, B., \\& Hildingsson, I. (2017). Birth preference in women undergoing treatment for childbirth fear: A randomised controlled trial. Women and Birth, 30(6), 460-467.'}, {'url': 'https://jep.ro/images/pdf/cuprins_reviste/78_art_4.pdf', 'label': 'Paica, C. I. (2017). Prenatal and postnatal psychological counselling the conscious assumption of the maternal role. Journal of Experiential Psychotherapy, 20(2), 24-31.'}, {'url': 'https://dune.univ-angers.fr/documents/dune334', 'label': "Poirier, P. (2011). La préparation à la naissance et à la parentalité, ce qu'en savent les futurs parents \\[Université d'Angers\\]."}, {'url': 'https://doi.org/10.1007/s12453-017-0139-6', 'label': 'Pollmann, M. T. F., \\& Hoffenaar, P. J. (2017). Haptonomische zwangerschapsbegeleiding en de prenatale gehechtheid van ouders aan hun kind. Kind En Adolescent, 38(2), 108-119.'}, {'url': 'https://avesis.istanbul.edu.tr/gulay.rathfisch/egitim', 'label': 'Rathfisch, Gulay. (2019). Prenatal haptonomy course notes \\[PowerPoint slide\\]. İstanbul.'}, {'url': 'https://doi.org/10.1016/j.mhp.2017.03.001', 'label': 'Stojanow, K., Rauchfuss, M., Bergner, A., \\& Maier, B. (2017). Anxiety in high-and low-risk pregnancies and its influence on perinatal outcome. Mental Health and Prevention, 6, 51-56.'}, {'url': 'https://dumas.ccsd.cnrs.fr/dumas-02505621', 'label': "Tison, R. B. (2019). L' accompagnement haptonomique prénatal : attentes et vécu des couples. ESF - UCA - École de Sages-Femmes - Clermont-Auvergne."}, {'url': 'http://bibnum.univ-lyon1.fr/nuxeo/nxfile/default/e19c6302-d00e-4fc8-a916-2115e3bdb85f/file:content/Msfb_2016_VIGNOLI_Lucie.pdf', 'label': "Vignoli, L. (2016). Préparation à la naissance et à la parentalité en couple: ce qu'en pensent les primipères."}, {'url': 'https://doi.org/10.7202/039288ar', 'label': "Vinit, F. (2010). Réflexions autour de l'accompagnement haptonomique de la grossesse. Filigrane, 18(2), 38-50."}, {'url': 'https://doi.org/10.1016/j.ajog.2009.07.041', 'label': 'Woods, S. M., Melville, J. L., Guo, Y., Fan, M., \\& Gavin, A. (2010). Psychosocial stress during pregnancy. American Journal of Obstetrics \\& Gynecology, 202(1), 61.e1-61.e7.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process. This study was conducted to determine the effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment.\n\nMethods: The population of the randomized controlled experimental study consisted of 72 primiparous pregnant women within the gestational weeks 22-28 who presented to the Obstetrics and Gynecology Polyclinic of a state hospital in Turkey for check-up (36 experimental subjects, 36 control subjects).', 'detailedDescription': 'Background: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process.\n\nAim: This study was conducted to determine the effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment.\n\nMethods: The population of the randomized controlled experimental study consisted of 72 primiparous pregnant women within the gestational weeks 22-28 who presented to the Obstetrics and Gynecology Polyclinic of a state hospital in Turkey for check-up (36 experimental subjects, 36 control subjects). A home visit was made to the experimental group, and haptonomy was applied for at least 30 minutes, once a week, for 7 weeks (with the researcher for 3 weeks, with the husband by providing the training brochure and video that will help the practice for the next 4 weeks). The control group did not receive any treatment. Data were collected at the first, third, and seventh weeks using the Pregnancy Description form, the Perceived Stress Scale (PSS), the Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A), and the Prenatal Attachment Inventory (PAI). Number and percentage distribution, chi-square test, t test, Mann-Whitney U test, repeated measures, two-way analysis of variance, Friedman test, and Cohen d test were used in the evaluation of the data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous pregnant women who were married,\n* aged 18 years and over,\n* literate,\n* living in the city center,\n* not having any health problems in themselves and their infants,\n* with spontaneous pregnancy at 22-28 weeks of gestation,\n* without perception and communication problems,\n* and who agreed to participate in the study were included in the study.\n\nExclusion Criteria:\n\n• Multiparity'}, 'identificationModule': {'nctId': 'NCT05240092', 'briefTitle': 'The Effect of Haptonomy Applied to Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'The Effect of Haptonomy Applied to Pregnant Women on Perceived Stress, Fear of Childbirth and Prenatal Attachment', 'orgStudyIdInfo': {'id': 'TR SIVAS02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Haptonomy Group', 'description': 'A home visit was made to the experimental group, and haptonomy was applied for at least 30 minutes, once a week, for 7 weeks (with the researcher for 3 weeks, with the husband by providing the training brochure and video that will help the practice for the next 4 weeks).', 'interventionNames': ['Behavioral: Haptonomy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care Group', 'description': 'The control group did not receive any treatment.'}], 'interventions': [{'name': 'Haptonomy', 'type': 'BEHAVIORAL', 'otherNames': ['Control Group'], 'description': 'Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.', 'armGroupLabels': ['Haptonomy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Sukran Ertekin Pinar', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Sükran Ertekin Pinar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr', 'investigatorFullName': 'Sukran Ertekin Pinar', 'investigatorAffiliation': 'Cumhuriyet University'}}}}