- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07935577
Effect of a Confidence-Building and Diaphragmatic Breathing-Assisted Graded Exposure on Kinesiophobia and Anxiety During First Mobilization Among Women After Cesarean Section
This quasi-experimental study will evaluate whether a program combining confidence building, diaphragmatic breathing (slow, deep belly breathing), and gradual exposure to movement can reduce fear of movement and anxiety during first mobilization after cesarean section.
The study will include two groups without random assignment. The intervention group will receive the combined program in addition to routine hospital care. The control group will receive routine hospital care only. Fear of movement and anxiety will be assessed before and after the intervention period in both groups. Changes will be compared between the groups to evaluate the effects of the program.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ghadeer F Abbas
- Numéro de téléphone: +9647808020105
- E-mail: ghadeer.f@s.uokerbala.edu.iq
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:Women aged 18 years or older who have undergone cesarean section.
2. Women who are medically stable and approved by the responsible healthcare team for first mobilization.
3. Women who have not yet started their first out-of-bed mobilization at the time of baseline assessment.
4. Women who are able to understand the intervention instructions, communicate with the researcher, and complete the study assessment tools.
5. Women who are willing to participate and provide written informed consent.
Exclusion Criteria : Medical instability or a clinical contraindication to first mobilization.
7. Severe postoperative complications that prevent safe mobilization. 8. Neurological or musculoskeletal disorders that substantially impair the ability to stand or walk safely.
9. Cognitive or communication difficulties that prevent understanding the intervention or valid completion of the study assessment tools.
10. A severe psychiatric condition that substantially interferes with informed consent, participation in the intervention, or valid completion of the study assessments, as determined according to the approved study protocol.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Confidence-Building and Breathing-Assisted Graded Exposure Group
|
The researcher will deliver the program in addition to routine hospital care after the clinical team confirms that the woman is medically stable and cleared for first mobilization after cesarean section. Confidence building will include supportive discussion (approximately 5 minutes) to identify concerns, explain the movement sequence, and provide realistic reassurance and encouragement. Guided mental rehearsal (approximately 10 minutes) will help the woman mentally prepare for sitting, standing, and walking. This will be followed by 3 minutes of slow, comfortable diaphragmatic breathing without straining the surgical area. Graded exposure-assisted mobilization will progress through five levels: in-bed position adjustment, upright sitting, sitting at the bedside, supported standing, and short assisted walking. Each level will be attempted according to clinical stability and tolerance, with positive feedback after successful completion. |
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Aucune intervention: Routine Care Control Group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia (TSK-17)
Délai: Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups.
|
kinesiophobia will be assessed in both groups using the 17-item Tampa Scale for Kinesiophobia (TSK-17). Total scores range from 17 to 68, with higher scores indicating greater fear of movement. Changes from baseline to the post-intervention assessment will be compared between the intervention and control groups. |
Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Anxiety Measured by the Visual Analogue Scale for Anxiety (VAS-A)
Délai: Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups
|
Anxiety will be assessed in both groups using a 100-mm Visual Analogue Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 100 (worst imaginable anxiety). Higher scores indicate greater anxiety. Changes from baseline to the post-intervention assessment will be compared between the intervention and control groups. |
Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Bandura, A. (1997). Self-efficacy: The exercise of control. W. H. Freeman. Gonella, S., Delfino, C., Rolfo, M., Rizzo, A., Esposito, V., Berchialla, P., & Campagna, S. (2021). Effects of a video-based preoperative educational intervention plus nurse-led reinforcement discussion on knowledge, self-efficacy, and resilience in patients undergoing major surgery. Clinical Nursing Research, 30(6), 753-761. https://doi.org/10.1177/1054773820986916 Peng, J., Luo, Y., Feng, L., Xiao, J., Feng, F., Zheng, Y., Bao, L., Yang, S., & Wu, X. (2025). Targeting kinesiophobia after thoracic surgery with an integrated protection motivation and exposure intervention: A randomized controlled trial. Journal of Pain Research, 18, 6911-6920. https://doi.org/10.2147/JPR.S544205 Prokopowicz, A., & Byrka, K. (2021). Effectiveness of mental simulations on the early mobilization of patients after cesarean section: A randomized controlled trial. Scientific Reports, 11, 22634. https://doi.org/10.1038/s41598-021-02036-1 Rittharomya, J., Krua-aum, P., & Aree-Ue, S. (2025). Effectiveness of a rehabilitation self-efficacy program on postoperative outcomes in older adults with hip fracture: A randomized controlled trial. Pacific Rim International Journal of Nursing Research, 29(1), 91-107. https://doi.org/10.60099/prijnr.2025.269063 Watson, G. M., Sutherland, J., Lacey, C., & Bridgman, P. G. (2022). A randomised crossover trial of QT response to hyperventilation-induced anxiety and diaphragmatic breathing in patients with stress cardiomyopathy and in control patients. PLoS ONE, 17(3), e0265607. https://doi.org/10.1371/journal.pone.0265607
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
- CS -CBDB -GE -KA-2026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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