- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07715487
The Effect of Bedside Yoga Intervention on Early Mobilization in Children
The Effect of Bedside Yoga Intervention on Early Mobilization in Children Undergoing Surgery
The postoperative period is a critical phase in which early mobilization can accelerate recovery and reduce the risk of complications. Early movement improves lung ventilation, thereby decreasing the likelihood of atelectasis and pneumonia, while also enhancing circulation to prevent deep vein thrombosis and pulmonary embolism. Furthermore, it promotes bowel motility, reduces the risk of constipation and ileus, preserves muscle strength, and improves overall well-being. Early mobilization has also been associated with better pain control, enhanced psychological well-being, reduced complication rates, and shorter hospital stays. However, in pediatric patients, factors such as pain, anxiety, and fear may delay the mobilization process.
Yoga has emerged as a promising non-pharmacological intervention due to its combination of breathing exercises, relaxation techniques, and gentle physical movements. Previous studies have demonstrated that yoga can reduce pain perception, improve pain tolerance, alleviate stress-related symptoms, and support physical recovery in children. Evidence suggests that yoga-based interventions may contribute to pain management by promoting relaxation and reducing psychological distress. In postoperative settings, bed-based yoga exercises have been reported to facilitate musculoskeletal relaxation, improve respiratory function, decrease anxiety and stress levels, and encourage earlier mobilization. Systematic reviews have further indicated that yoga may enhance both physical and psychological recovery following surgery, particularly through its effects on pain reduction and functional rehabilitation.
Although the benefits of bed-based yoga have been documented in adult surgical populations, research focusing on pediatric surgical patients remains limited. Therefore, this study aims to evaluate the effect of bed-based yoga on early mobilization in pediatric surgical patients during the postoperative period. By investigating the effectiveness of this non-pharmacological intervention, the study seeks to address an important gap in the literature and contribute to evidence-based postoperative nursing care practices.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Early mobilization in the postoperative period is an important approach that accelerates the recovery process and reduces the risk of complications. Movement improves lung ventilation, thereby decreasing the risk of atelectasis and pneumonia, while supporting circulation and preventing the development of deep vein thrombosis and embolism. In addition, it promotes bowel motility, reducing the risk of constipation and ileus; preserves muscle strength, preventing muscle atrophy; and enhances patients' overall well-being. Its contribution to pain control and psychological well-being is also among the significant benefits of early mobilization. Early mobilization is known to offer advantages such as reducing complications and shortening the length of hospital stay. However, managing this process in pediatric patients is more challenging, as factors such as pain and anxiety may delay mobilization.
Yoga, as a non-pharmacological intervention, has been applied in various patient groups and has yielded positive outcomes due to its muscle-relaxing effects, breath control techniques, and ability to promote psychological relaxation. In recent years, the effects of yoga on pain management in children have increasingly attracted research attention. Pain in children is associated not only with physical discomfort but also with psychological stress, anxiety, and distress, all of which may negatively affect the recovery process. Because yoga provides a holistic mind-body approach that incorporates breathing techniques, relaxation exercises, and gentle physical movements, it is considered an effective method for controlling pain in children. Studies have shown that regular yoga practice may reduce pain perception in children, enhance pain tolerance, and alleviate stress-related pain through its calming effects on the central nervous system. In particular, gentle bed-based yoga exercises performed by children experiencing postoperative pain have been reported to support musculoskeletal relaxation, accelerate recovery, and reduce the need for pharmacological pain management.
A systematic review examining the use of yoga for pain management in children revealed that yoga interventions may provide analgesic effects in both chronic and acute pain conditions. Studies involving pediatric patients undergoing cancer treatment have demonstrated that regular yoga practice reduces chemotherapy-related pain and improves overall well-being. Furthermore, when combined with breathing exercises and meditation, yoga has been shown to increase children's tolerance to pain and reduce perceived pain intensity.
In a systematic review evaluating the effectiveness of yoga interventions during the postoperative recovery process, more than 20 randomized controlled trials involving patients who had undergone different surgical procedures were examined, and the effects of yoga on physical and psychological recovery after surgery were analyzed in detail. According to the findings, bed-based yoga practices play a significant role in reducing postoperative pain, improving respiratory function, and promoting early mobilization. It was emphasized that yoga exercises, particularly those involving deep-breathing techniques and gentle physical movements, help prevent postoperative muscle stiffness and joint limitations. In addition, yoga interventions were found to reduce anxiety and stress levels, enabling patients to manage the postoperative period more comfortably and effectively. The review also reported that yoga accelerated the mobilization process and reduced complication rates, particularly among patients undergoing minimally invasive and orthopedic surgeries. The authors further highlighted the importance of considering yoga as a standard component of postoperative care and advocated for its greater inclusion among non-pharmacological approaches in nursing practice.
Studies conducted in adult surgical patients have demonstrated that bed-based yoga contributes positively to pain management and the mobilization process. However, there remains a limited number of studies investigating the effects of bed-based yoga interventions in pediatric surgical patients.
This study aims to contribute to the limited body of research evaluating the effect of postoperative bed-based yoga interventions on early mobilization in pediatric surgical patients. In this context, the study is expected to address an important gap in the literature regarding the effectiveness of non-pharmacological interventions in postoperative care.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Emel YÜRÜK, PHD
- Numero di telefono: 05387115176
- Email: emelyurukbal@gmail.com
Backup dei contatti dello studio
- Nome: Aslıhan HACISALİHOĞLU, MSC
- Numero di telefono: 5342612377
- Email: asli.han.hem@gmail.com
Luoghi di studio
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Adana, Turchia (Türkiye)
- Adana City Training and Research Hospital
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Contatto:
- Emel YÜRÜK, PHD
- Numero di telefono: 3229110001
- Email: emelyurukbal@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Hospitalized in a pediatric surgery unit for surgery.
- Able to participating in pediatric yoga.
- Able to understand and communicate in Turkish.
Exclusion Criteria:
- none
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: No Intervention: GROUP WITH STANDARD CARE AND TREATMENT
Mothers will be informed about the study, and verbal consent will be obtained. Written informed consent will subsequently be secured using the Informed Consent Form. During the preoperative period, the Descriptive Information Form will be completed. In the postoperative period, mobilization activities will be monitored on an hourly basis. At the postoperative 8th hour, vital signs will be recorded, and the Wong-Baker Faces Pain Rating Scale and the Visual Analog Scale for Fatigue will be administered. A pedometer will then be attached to the child, after which the child will be mobilized according to the standard clinical protocol of the unit. Five minutes after mobilization, vital signs will be reassessed, and the Wong-Baker Faces Pain Rating Scale, Visual Analog Scale for Fatigue, Mobilization Assessment Form, Patient Mobility Scale, and Observer Mobility Scale will be completed. The Observer Mobility Scale will be evaluated independently by both the mother and the res |
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Sperimentale: Pediatric Yoga Group
Mothers will be informed about the study, and verbal consent will be obtained. Written informed consent will then be secured using the Informed Consent Form. During the preoperative period, the Descriptive Information Form will be completed, and each child will receive one session of pediatric yoga training to familiarize them with the intervention. At the postoperative 8th hour, vital signs will be recorded, and the Wong-Baker Faces Pain Rating Scale and the Visual Analog Scale for Fatigue will be administered. Following these assessments, the child will participate in a pediatric yoga session. Five minutes after the completion of the yoga session, vital signs will be reassessed, and the Wong-Baker Faces Pain Rating Scale and the Visual Analog Scale for Fatigue will be completed again. Subsequently, a pedometer will be attached to the child, and mobilization will be initiated according to the standard clinical protocol of the unit. |
The session begins with Pranayama (breathing exercises), specifically the Bee Breath (Bhramari Pranayama), in which the child produces a prolonged humming sound resembling the letter "M" with the mouth closed, first with the ears open and then with the ears gently covered.
Following the breathing exercise, yoga postures are performed using a storytelling approach.
The sequence includes the Butterfly Pose, Cactus Pose, Cat-Cow Pose, Sitting Bear Pose, and Butterfly Pose again, followed by repeating the postures in reverse order.
The session concludes with Shavasana (Corpse Pose), a relaxation posture maintained for 30 seconds.
Finally, the child is encouraged to express gratitude to their yoga partner and to themselves for participating in the session, after which the yoga session is concluded.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Wong-Baker Faces Pain Rating Scale
Lasso di tempo: Post-op Hour 8 5 min Post-Intervention 5 min Post-Mobilization
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The Wong-Baker FACES Pain Rating Scale (WB-FACES) is a visual analog scale used to assess pain intensity in both children and adults. The scale consists of six different facial expressions representing varying levels of pain intensity, scored from 0 to 10. A score of 0 indicates "no pain," whereas a score of 10 represents "the worst pain imaginable." The Wong-Baker FACES Pain Rating Scale was originally developed by Donna Wong and Connie Morain Baker in 1981 and was subsequently revised in 1983. The scale is commonly used to assess pain in children aged 3-18 years. Previous studies evaluating the scale in pediatric populations have reported that children prefer facial expression-based rating scales and find them easy to use. Furthermore, the Wong-Baker FACES Pain Rating Scale has been identified as one of the most accurate methods for measuring pain intensity in children. |
Post-op Hour 8 5 min Post-Intervention 5 min Post-Mobilization
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Visual Analog Scale for Fatigue (VAS-F)
Lasso di tempo: Post-op Hour 8 5 min Post-Intervention 5 min Post-Mobilization
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This scale is used to assess the severity of fatigue.
It consists of a 10-cm horizontal line with verbal descriptors at each end and is scored from 0 to 10.
A score of 0 indicates "no fatigue," whereas a score of 10 indicates "severe fatigue."
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Post-op Hour 8 5 min Post-Intervention 5 min Post-Mobilization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient Mobility Scale
Lasso di tempo: 5 min Post-Mobilization
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In the scale, the levels of pain and difficulty are determined by measuring the distance between the marked point and the value "0."
Each activity includes two separate subscale items.
Scoring for each item ranges from 0 to 15, and each activity is evaluated out of a maximum of 30 points.
Accordingly, the total score of the scale ranges from 0 to 120.
The overall score is calculated by summing the scores obtained from the four activities.
The resulting score reflects the level of pain and difficulty experienced by patients while performing these movements.
Higher scores indicate greater pain intensity and increased difficulty in performing the activity, whereas lower scores indicate reduced pain and fewer movement-related difficulties.
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5 min Post-Mobilization
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Observer Mobility Scale
Lasso di tempo: 5 min Post-Mobilization
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The Observer Mobility Scale was developed by Heye et al. in 2002 to assess patients' levels of independence while performing postoperative mobility activities, including turning in bed, sitting at the bedside, standing up, and walking. The Turkish validity and reliability study of the scale was conducted by Ayoğlu in 2011. In the Turkish version, Cronbach's alpha coefficients ranged between 0.61 and 0.75. Each item is scored on a 5-point scale, where a score of 1 indicates that the patient performs the activity completely independently, and a score of 5 indicates that the activity cannot be performed even with assistance. The total score is calculated by summing the scores obtained from the four mobility activities, resulting in a possible score range of 4 to 20. Higher scores indicate greater impairment in mobility and lower levels of independence. |
5 min Post-Mobilization
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Patient Monitoring Form
Lasso di tempo: 5 min Post-Mobilization
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The Patient Monitoring Form is a follow-up chart developed by the researchers to record patients' vital signs, including body temperature, heart rate, blood pressure, and respiratory rate.
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5 min Post-Mobilization
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Pedometer
Lasso di tempo: during first mobilization
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A pedometer is a portable device that objectively measures an individual's step count and physical activity level.
Considered a form of wearable technology, pedometers use motion sensors to record daily step counts, thereby providing a quantitative assessment of physical activity.
This device is commonly used to evaluate patients' mobility levels, particularly during the postoperative mobilization process following surgical procedures
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during first mobilization
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- Cukuova University
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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