Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial
Abstract Background Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information a...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3906-2 |
| _version_ | 1818453397224816640 |
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| author | Esther Aleo Luján Amanda Lopez-Picado Ana Rivas Belén Joyanes Abancens Marina Laura Rodríguez Rojo Patricia Fernández García Carmen Soto Beauregard Jaime Rodríguez Alarcón Carlos González Perrino Borja San Pedro de Urquiza Eva Arias Diamelis Rodriguez Carmen Esteban Polonio Maria José Torrejón |
| author_facet | Esther Aleo Luján Amanda Lopez-Picado Ana Rivas Belén Joyanes Abancens Marina Laura Rodríguez Rojo Patricia Fernández García Carmen Soto Beauregard Jaime Rodríguez Alarcón Carlos González Perrino Borja San Pedro de Urquiza Eva Arias Diamelis Rodriguez Carmen Esteban Polonio Maria José Torrejón |
| author_sort | Esther Aleo Luján |
| collection | DOAJ |
| description | Abstract Background Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies. Methods We propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2–16 years undergoing outpatient surgery (n = 188). Subjects will be randomised into two groups – (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient’s surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey. Conclusions This study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients. Trial registration ClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017. |
| first_indexed | 2024-12-14T21:38:20Z |
| format | Article |
| id | doaj.art-1cabab17f63147159f4072b6a9d750fb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T21:38:20Z |
| publishDate | 2020-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1cabab17f63147159f4072b6a9d750fb2022-12-21T22:46:32ZengBMCTrials1745-62152020-01-012111810.1186/s13063-019-3906-2Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trialEsther Aleo Luján0Amanda Lopez-Picado1Ana Rivas2Belén Joyanes Abancens3Marina Laura Rodríguez Rojo4Patricia Fernández García5Carmen Soto Beauregard6Jaime Rodríguez Alarcón7Carlos González Perrino8Borja San Pedro de Urquiza9Eva Arias10Diamelis Rodriguez11Carmen Esteban Polonio12Maria José Torrejón13Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Investigación Clinica y Ensayos Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Investigación Clinica y Ensayos Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de MadridServicio de Cirugía Pediátrica, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Servicio de Anestesiología y Reanimación, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Servicio de Anestesiología y Reanimación, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Supervisora de Enfermería del Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Servicio de Análisis Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)Abstract Background Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies. Methods We propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2–16 years undergoing outpatient surgery (n = 188). Subjects will be randomised into two groups – (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient’s surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey. Conclusions This study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients. Trial registration ClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.https://doi.org/10.1186/s13063-019-3906-2AnxietySurgeryClownHydroxyzineRandomised clinical trial |
| spellingShingle | Esther Aleo Luján Amanda Lopez-Picado Ana Rivas Belén Joyanes Abancens Marina Laura Rodríguez Rojo Patricia Fernández García Carmen Soto Beauregard Jaime Rodríguez Alarcón Carlos González Perrino Borja San Pedro de Urquiza Eva Arias Diamelis Rodriguez Carmen Esteban Polonio Maria José Torrejón Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial Trials Anxiety Surgery Clown Hydroxyzine Randomised clinical trial |
| title | Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial |
| title_full | Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial |
| title_fullStr | Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial |
| title_full_unstemmed | Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial |
| title_short | Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial |
| title_sort | pre operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non pharmacological distraction technique with a clown sonrisa study protocol for randomised double blind clinical trial |
| topic | Anxiety Surgery Clown Hydroxyzine Randomised clinical trial |
| url | https://doi.org/10.1186/s13063-019-3906-2 |
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