- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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".
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
Närke
-
Örebro, Närke, Švédsko, 701 13
- Centre for health care Sciences
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: usual care
The participants in the no intervention group were informed that they should continue living as usual
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Self reported health
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
adherence to and experience of the intervention
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Margareta HL Moller, professor, Örebro County Council
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
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