Prenatal Haptonomy-Based Support for Attachment and Partner Support
Effets des approches de soutien basées sur l'haptonomie pendant la période prénatale sur l'attachement prénatal et le soutien perçu du partenaire - Une étude contrôlée randomisée
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027.
Eligible participants will be informed about the study objectives, procedures, potential benefits and risks, and voluntary participation principles. Written informed consent will be obtained prior to enrollment. Participant confidentiality will be ensured in accordance with data protection regulations, and unique identification codes will be assigned.
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory (PAI), and Spousal Support Scale (SSS). Following baseline assessment, participants will be randomly allocated into one of three groups:
Partner-supported haptonomy group Mother-supported haptonomy group Midwife-supported haptonomy group The haptonomy-based intervention will be delivered once weekly for three consecutive weeks in a hospital-based setting. Each session will last approximately 30 minutes and will follow a standardized protocol including structured affective touch, body awareness facilitation, emotional observation, and structured session closure. All sessions will be conducted by a research assistant who completed the Prenatal Haptonomy Instructor Training (January 29-31, 2026). The principal investigator will supervise and monitor the scientific integrity of the study.
Outcome assessments will be conducted at three time points:
T0 (Baseline): Prior to intervention T1 (Post-session 1): 24-48 hours after the first haptonomy session T2 (Post-intervention): 24-48 hours after the third haptonomy session The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Data completeness will be checked after each assessment.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027. Participants will receive verbal and written information about the study, written informed consent will be obtained, and all data will be stored using coded identifiers in accordance with confidentiality principles.
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory, and Spousal Support Scale. Participants will then be randomly assigned to one of three groups: partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy. The haptonomy-based intervention will be delivered over three consecutive weeks, once per week, following a standardized protocol, with each session lasting approximately 30 minutes and conducted in a hospital setting. Interventions will be carried out by a research assistant trained in prenatal haptonomy and scientifically supervised by the principal investigator.
Haptonomy sessions will include structured affective touch, body awareness facilitation, emotional observation, and session closure, with no invasive procedures involved. Outcome assessments will be conducted at three time points: prior to the intervention (T0), 24-48 hours after the first session (T1), and 24-48 hours after the third session (T2). The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Collected data will be analyzed using statistical methods to evaluate the effects of haptonomy-based support approaches on prenatal attachment and perceived partner support.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hilal Ozbek
- Numéro de téléphone: +905053873773
- E-mail: hilal.ozbek@gop.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Simay Bartınlı, Msc
- Numéro de téléphone: +905423105598
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Pregnant women aged 18-45 years
- Attending antenatal follow-up at Tokat Gaziosmanpaşa University Hospital
- Gestational age between 20 and 32 weeks
- Ability to communicate in Turkish
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- High-risk pregnancy (e.g., preeclampsia, placenta previa, gestational diabetes requiring insulin)
- Diagnosed psychiatric disorder
- Multiple pregnancy
- Known fetal anomaly
- Participation in another interventional study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Partner-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support together with their partners once weekly for three consecutive weeks. |
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's partner. The protocol includes affective touch facilitated by the partner, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. |
|
Expérimental: Mother-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support together with their mothers once weekly for three consecutive weeks. |
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's mother. The protocol includes affective touch facilitated by the mother, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. |
|
Expérimental: Midwife-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support delivered by a trained midwife once weekly for three consecutive weeks. |
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted by a trained midwife. The protocol includes affective touch provided by the midwife, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prenatal Attachment
Délai: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
|
Change from baseline in prenatal attachment as measured by the Prenatal Attachment Inventory (PAI). The Prenatal Attachment Inventory (PAI), developed by Mary Muller (1993), consists of 21 items rated on a 4-point Likert scale (1 = Almost Never, 4 = Almost Always). Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment. There are no reverse-scored items. The scale is unidimensional and evaluated using total score. |
Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceived Partner Support
Délai: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
|
Change from baseline in perceived partner support as measured by the Spouse Support Scale (SSS). The Spouse Support Scale (SSS), developed by Yıldırım (2005), consists of 13 items rated on a 5-point Likert scale (1 = Not appropriate at all, 5 = Completely appropriate). Total scores range from 13 to 65. Higher total scores indicate higher perceived partner support. There are no reverse-scored items. The scale is evaluated using the total score. |
Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hilal Ozbek, Tokat Gaziosmanpasa University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- TR TOKAT03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared due to participant confidentiality and institutional data protection policies. Only aggregate study results will be published.
Informations sur les médicaments et les dispositifs, documents d'étude
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