- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07906483
Effect of Baduanjin Exercise on Pain, Fatigue, and Quality of Recovery After Abdominal Surgery
The Effect of Baduanjin Exercise on Pain, Fatigue, and Quality of Recovery in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of Baduanjin exercise on pain, fatigue, fatigue severity, and quality of recovery in patients undergoing abdominal surgery.
A total of 60 participants will be randomly assigned to an intervention group or a control group. Before surgery, participants in the intervention group will receive instruction in Baduanjin exercises and perform the exercises once to learn the technique. After hospital discharge, they will continue the Baduanjin exercise program three days per week for six weeks. Participants in the control group will receive standard hospital care without Baduanjin exercise.
At the end of weeks 3 and 6, pain, fatigue, fatigue severity, and quality of recovery will be assessed using the Visual Analog Scale (VAS), Fatigue Scale, Fatigue Severity Scale, and Quality of Recovery-40 (QoR-40), respectively. Outcomes will be compared between the intervention and control groups.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study aims to evaluate the effects of Baduanjin exercise on pain, fatigue, fatigue severity, and quality of recovery in patients undergoing abdominal surgery. The study is planned as a randomized, controlled, pretest-posttest experimental study involving 60 patients undergoing abdominal surgery at Gümüşhane State Hospital, Türkiye. Participants will be randomly assigned to an intervention group (n=30) or a control group (n=30). Before surgery, participants in the intervention group will be taught how to perform Baduanjin exercises and will perform the exercises once under instruction to learn the technique. After hospital discharge, participants will continue the Baduanjin exercise program three days per week for six weeks. Participants in the control group will receive standard hospital care without Baduanjin exercise. At the end of weeks 3 and 6, outcomes will be assessed in both groups using the Visual Analog Scale (VAS) to measure pain intensity, the Fatigue Scale to assess fatigue, the Fatigue Severity Scale to assess fatigue severity, and the Quality of Recovery-40 (QoR-40) questionnaire to evaluate quality of recovery. The results will be compared between the intervention and control groups to determine the effects of the Baduanjin exercise program on pain, fatigue, fatigue severity, and quality of recovery following abdominal surgery.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: NİRAN ÇOBAN, Asst. prof.
- Telefonní číslo: 05301586912
- E-mail: nirancoban@gmail.com
Studijní záloha kontaktů
- Jméno: Nurşen Kulakaç, Assoc. Prof.
- E-mail: nrsnklkc@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients aged 18 years and older and younger than 70 years.
- Patients undergoing abdominal surgery.
- Patients who voluntarily agree to participate in the study and provide informed consent.
- Patients with a body mass index (BMI) below 40 kg/m².
- Patients with a Standardized Mini-Mental State Examination score of 24 or higher.
- Patients who are able to read and write.
Exclusion Criteria:
- Patients with communication or comprehension difficulties.
- Patients who receive sedation.
- Patients who have difficulty understanding or speaking Turkish.
- Patients with a psychiatric disorder who are receiving medication.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Standart care
Participants in this group will receive standard hospital care without Baduanjin exercise. Pain, fatigue, fatigue severity, and quality of recovery will be assessed at the end of weeks 3 and 6 using the Visual Analog Scale (VAS), Fatigue Scale, Fatigue Severity Scale, and Quality of Recovery-40 (QoR-40), respectively. |
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Experimentální: Baduanjin Exercise Group
Participants in this group will receive instruction in Baduanjin exercises before surgery and will perform the exercises once under instruction to learn the technique. After hospital discharge, participants will continue the Baduanjin exercise program three days per week for six weeks. Pain, fatigue, fatigue severity, and quality of recovery will be assessed at the end of weeks 3 and 6 using the Visual Analog Scale (VAS), Fatigue Scale, Fatigue Severity Scale, and Quality of Recovery-40 (QoR-40), respectively. |
Participants in the intervention group will be taught Baduanjin exercises before surgery and will perform the exercises once under instruction to learn the technique. After hospital discharge, participants will continue the Baduanjin exercise program three days per week for six weeks. Pain, fatigue, fatigue severity, and quality of recovery will be assessed at the end of weeks 3 and 6 using the Visual Analog Scale (VAS), Fatigue Scale, Fatigue Severity Scale, and Quality of Recovery-40 (QoR-40), respectively. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Effect of Baduanjin on Pain
Časové okno: At the end of weeks 3 and 6 after hospital discharge.
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Visual Analog Scale (VAS): The Visual Analog Scale (VAS) is a commonly used tool for assessing pain. It consists of a 10-cm (100-mm) line ranging from 0 (no pain) to 10 (worst imaginable pain). In this study, the VAS will be used to assess pain in patients undergoing abdominal surgery at the end of weeks 3 and 6 after hospital discharge to evaluate the effect of Baduanjin exercise on pain. |
At the end of weeks 3 and 6 after hospital discharge.
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The Effect of Baduanjin on Fatigue
Časové okno: At the end of weeks 3 and 6 after hospital discharge.
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Fatigue Scale (FS): The Fatigue Scale was developed by Beurskens et al. in 2000 to assess chronic fatigue. The scale consists of 20 items and evaluates fatigue over the previous two weeks across four dimensions: subjective fatigue perception, concentration, motivation, and physical activity. The Turkish version was validated by Ergin et al. in 2009. The total score ranges from 20 to 140, with higher scores indicating greater chronic fatigue. In this study, the Fatigue Scale will be used to assess fatigue in patients undergoing abdominal surgery at the end of weeks 3 and 6 after hospital discharge to evaluate the effect of Baduanjin exercise on fatigue. |
At the end of weeks 3 and 6 after hospital discharge.
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The Effect of Baduanjin Exercise on Fatigue Severity
Časové okno: At the end of weeks 3 and 6 after hospital discharge.
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Fatigue Severity Scale (FSS): The Fatigue Severity Scale was developed by Krupp et al. in 1989 to assess fatigue severity, initially in patients with multiple sclerosis and systemic lupus erythematosus. It consists of nine items assessing the subjective severity of fatigue during the previous week. Each item is rated on a seven-point scale, and the total score is calculated as the arithmetic mean of the item scores. Higher scores indicate greater fatigue severity, and a score of approximately 4 or above generally suggests substantial fatigue. The Turkish validity and reliability study was conducted by Gencay Can et al. in 2012. In this study, the Fatigue Severity Scale will be used to assess fatigue severity in patients undergoing abdominal surgery at the end of weeks 3 and 6 after hospital discharge to evaluate the effect of Baduanjin exercise on fatigue severity. |
At the end of weeks 3 and 6 after hospital discharge.
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The Effect of Baduanjin Exercise on Quality of Recovery
Časové okno: At the end of weeks 3 and 6 after hospital discharge.
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Quality of Recovery-40 (QoR-40): The Quality of Recovery-40 (QoR-40) was developed by Myles et al. in 2000 and its Turkish validity and reliability were evaluated by Karaman et al. in 2014. The questionnaire consists of 40 items across five dimensions: emotional state, physical comfort, patient support, physical independence, and pain. Each item is rated on a five-point Likert scale, and the total score ranges from 40 to 200. Higher scores indicate better postoperative physical and emotional well-being, whereas lower scores indicate poorer quality of recovery. In this study, the QoR-40 will be used to assess quality of recovery in patients undergoing abdominal surgery at the end of weeks 3 and 6 after hospital discharge to evaluate the effect of Baduanjin exercise on postoperative recovery. |
At the end of weeks 3 and 6 after hospital discharge.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Nurşen Kulakaç, Assoc. Prof., Gümüşhane Universıty
Publikace a užitečné odkazy
Obecné publikace
- Wu D, Li J, Dong H, Zheng Y, Liu Z, Shen Y, Cui H. Effect of Baduanjin on postoperative activity tolerance, lung function and negative emotions in patients with lung cancer: a protocol for systematic review and meta-analysis. BMJ Open. 2025 May 19;15(5):e093152. doi: 10.1136/bmjopen-2024-093152.
- Wan Y, Fu Y, Bian Z, Wang C, Sun R, Lu Y, Lv H, Xuan L. Effects of traditional Chinese exercises for upper-limb dysfunction following breast cancer surgery: protocol for a systematic review and meta-analysis. BMJ Open. 2026 May 18;16(5):e112564. doi: 10.1136/bmjopen-2025-112564.
- Liu X, Hao X, Zhang W, Zhang F, Liu H. Baduanjin sequential therapy's effects on quality of life and cardiac function in post-cardiac surgery heart disease patients: A systematic review. Medicine (Baltimore). 2026 Jan 2;105(1):e46855. doi: 10.1097/MD.0000000000046855.
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
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