- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01523561
Influencing Adolescent Girls´ With Creative Dance Twice Weekly
Influencing Adolescent Girls With Internalizing Problems With Creative Dance Twice Weekly. A Randomised, Controlled Study
The aim of this study is to evaluate if creative dance twice weekly can influence girls wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic problems and/or stress.
Specific objectives are
- To assess the effect of the dance intervention in reducing psychosomatic problems (such as pain in the head, neck, shoulder or stomach), stress and depression
- Determine which factors are important for continuing dancing and keeping up new habits
- A cost-effectiveness analyse of the health outcome.
Geographical area: Örebro County (population 276,000)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The school nurses asked girls aged 13-18 years old, who searched for psychosomatic problems, if they wished to participate in the dance project. Recruitment of girls where also carried out in information about the project at parent meetings and in school classrooms. 143 girls completed the base-line questionnaire, 138 met the inclusion criteria and were included. Randomization was carried out to intervention and control group.
The quantitative data collection is carried out with a questionnaire. Participants in the dance intervention and the control group will response to this questionnaire at 7 times during the study, at start and every six months over a total period of 3 years.
Girls who are found to be at risk of having severe depression (> 34 points) in the depression scale CES-DC met with an experienced licensed psychologist. This was to explore if there was a need for extended support and help and the girl's parents and Child and Adolescent Psychiatric Care was contacted in most cases and if there was a risk for suicide. The results from the depression scale at base - line (CES-DC) showed that 81% of the girls in the study had depressive symptoms and 29% had high levels of depressive symptoms.
The qualitative interviews were performed in order to explore the girls experience of the dance lessons and to assess if and/or how dance intervention has affected her self-esteem in any way. These interviews were conducted on a strategic sample of 20 girls who participated in the dance intervention.
The dance intervention took place in a gym in Örebro twice weekly for a period of 1 year under the guidance of two dance class teachers (one at a time). The duration of the class was 75 minutes and the dance training was always carried out to popular and suitable music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz, aerobic dance and contemporary dance. African dance, to the music of African drums, was used in the warm up section. The dance class always ended with a 10-min-relaxation training. The dance intervention had a strong focus on emphasizing the participants' resources and creates a feeling of affinity. The dance teachers encouraged them to listen to signals from the body, reducing focus on the performance and "become part of the movement".
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
Närke
-
Örebro, Närke, Svezia, 701 13
- Centre for health care Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
The study population comprised adolescent girls with internalizing problems who had recurrent visits to the school nurse due to psychosomatic symptoms such as:
- pain in the head, stomach, neck, back and/or shoulder.
- persistent feelings of tiredness
- being worried
- in low spirit or depressed were also inclusion criteria.
Exclusion Criteria:
- severe hearing impairment
- intellectual disability
- difficulties with the Swedish language or
- if the CAP had advised against participation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: usual care
The participants in the no intervention group were informed that they should continue living as usual
|
|
|
Sperimentale: dance intervention
The dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers.
The duration of the class was 75 min.
and the dance training was always carried out to popular music.
The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise.
During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance.
African dance was used in the warm up section.
The dance class always ended with a relaxation.
The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity.
Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged.
|
The dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers.
The duration of the class was 75 min.
and the dance training was always carried out to popular music.
The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise.
During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance.
African dance was used in the warm up section.
The dance class always ended with a relaxation.
The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity.
Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Self reported health
Lasso di tempo: change from baseline to follow up at 20 months
|
the single-item question "How do you rate your general health?" is frequently used in national and international surveys.
The response alternatives is 1.
Very poor, 2. Poor, 3. Neither good nor poor, 4. Good, 5. Very good.
Measuring general health with a five-degree scale has been agreed upon in the EU.
|
change from baseline to follow up at 20 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
adherence to and experience of the intervention
Lasso di tempo: change baseline to follow up at 20 months
|
The adherence to the dance intervention was measured by registering attendance at every dance session during the intervention period.
Cancellations were made by telephone or text message.The experience of the dance intervention was evaluated with a graphic rating scale, a modified Visual Analogue Scale with five discrete alternatives.The question was "How do you experience dancing while you perform it?";
the rating scale started at "entirely negative" and ended at "entirely positive."
Cut-off was set between "neutral" and "entirely positive".
|
change baseline to follow up at 20 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Margareta HL Moller, professor, Örebro County Council
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- MMO027
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 .
Prove cliniche su Adolescente - Problema emotivo
-
Jouf UniversityCompletatoTerapia cognitivo comportamentale e problem solving | Disturbi dell'autismo e stress maternoEgitto, Arabia Saudita
Prove cliniche su dance group
-
National Taiwan University HospitalCompletato
-
Vilnius UniversityCompletatoSano | Fatica | Ansia | Disagio psicologico | Benessere | Salute mentale | Disturbi della depressione | Consapevolezza del corpo | VitalitàLituania
-
Anne KloosCompletatoMalattia di HuntingtonStati Uniti
-
Virginia Polytechnic Institute and State UniversityCompletato
-
Universidad Catolica Silva HenriquezUniversidad Arturo PratIscrizione su invitoMalattie sovrappeso, obesità e non comunibiliChile
-
McMaster UniversityReclutamentoFragilità | Sindrome da fragilità | Anziani fragili | Fragilità nell'invecchiamentoCanada
-
Universidad Central de VenezuelaCompletatoPulpite | Terapia canalare | Pulpite - Irreversibile | PulpotomiaVenezuela
-
University of Erlangen-Nürnberg Medical SchoolCompletatoCavalatori di cancro e attività fisicaGermania
-
Bursa City HospitalReclutamentoBlocco regionale per il controllo del dolore | Chirurgia toracoscopica videoassistita | Funzioni polmonari | Blocchi regionaliTacchino
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito