- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ghadeer F Abbas
- Telefonní číslo: +9647808020105
- E-mail: ghadeer.f@s.uokerbala.edu.iq
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
|
Žádný zásah: Routine Care Control Group
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia (TSK-17)
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Anxiety Measured by the Visual Analogue Scale for Anxiety (VAS-A)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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