Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000328370
Ethics application status
Approved
Date submitted
30/06/2008
Date registered
15/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are the Bach-flower remedies effective for improvement of self-esteem and life quality in elderly with lower self-esteem?
Scientific title
Are the Bach-flower remedies effective for improvement of self-esteem and life quality in elderly with lower self-esteem
Secondary ID [1] 611 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower self-esteem in elderly people 3266 0
Condition category
Condition code
Alternative and Complementary Medicine 3430 3430 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Bach-flower remedies are solutions obtained through the transference of some flowers vibration to water, therefore, this is an energetic intervention. They are used to rebalance the emotions and state of mind. The Bach-flower remedies are manipulated in sterilized bottles which 30 ml of Brandy solution 30% which contains 2 drops from each Mother-essence from the chosen remedy. In this study will be prepared 2 bottles for each volunteer for an interval of 45 days, where this interval will be repeated 2 times, totalling 90 days of intervention. The couple bottles contains the same preparation (if the volunteer is from the experimental group, the 2 bottles contains Bach-flower remedies. If from the placebo group, the bottles contains only Brandy solution 30%). Must be taken 4 drops, 4 times a day, directly in the mouth or diluted in some liquid (water, tea, juice).
Intervention code [1] 3007 0
Treatment: Other
Comparator / control treatment
The placebo will receive 30 ml of Brandy solution 30% without any Bach-flower remedy. In this study will be prepared 2 bottles for each volunteer for an interval of 45 days, where this interval will be repeated 2 times, totalling 90 days of intervention. Must be taken 4 drops, 4 times a day, directly in the mouth or diluted in some liquid (water, tea, juice).
Control group
Placebo

Outcomes
Primary outcome [1] 4325 0
Improvement in the Dela Coleta self-esteem score
Timepoint [1] 4325 0
At the baseline and 45 and 90 days after first intervention commencement
Primary outcome [2] 4326 0
Improvement in the WHO Quality of Life (WHOQOL) and Additional WHO Elderly Quality of Life(WHOQOL-OLD) scores
Timepoint [2] 4326 0
At the baseline and 90 days after first intervention commencement
Secondary outcome [1] 7292 0
Identify the most frequent Bach Flower Remedies among the volunteers of the research. In the Bach-flower remedies exist 38 essences. During the interview, the volunteer must choose 6 among the 38 essences (6 essences in each encounter), which will be registered in the volunteer record.
Timepoint [1] 7292 0
At the end on the last intervention

Eligibility
Key inclusion criteria
Dela Coleta self-esteem score < 9
Able to understand and answer the questionnares
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of drugs for anxiety or depression
2. Use of some energetic complementary pratice like Acupunture, Healing Touch, Reiki, Aromatherapy, Cromotherapy and Flowers Essences
3. Presence of cognitive deficit by mini-mental test

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing for the first volunteer. The later volunteers were allocated alternately in the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1004 0
Brazil
State/province [1] 1004 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3535 0
Government body
Name [1] 3535 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP)
Country [1] 3535 0
Brazil
Primary sponsor type
Individual
Name
Ruth Natalia Teresa Turrini
Address
Av. Dr. Enéas de Carvalho Aguiar, 419 - 3o andar
Cerqueira Cesar
São Paulo - SP
CEP 05403-000
Country
Brazil
Secondary sponsor category [1] 3173 0
Individual
Name [1] 3173 0
Sheila Katia Cozin
Address [1] 3173 0
Av. Dr. Eneas de Carvalho Aguiar, 419 - 3o andar
Cerqueira Cesar
Sao Paulo - SP
CEP 05403-000
Country [1] 3173 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5573 0
Research and Ethics Committee from Nursing School of University of Sao Paulo
Ethics committee address [1] 5573 0
Ethics committee country [1] 5573 0
Brazil
Date submitted for ethics approval [1] 5573 0
14/12/2007
Approval date [1] 5573 0
18/01/2008
Ethics approval number [1] 5573 0
700/2007/CEP-EEUSP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28671 0
Address 28671 0
Country 28671 0
Phone 28671 0
Fax 28671 0
Email 28671 0
Contact person for public queries
Name 11828 0
Ruth Natalia Teresa Turrini
Address 11828 0
Av. Dr. Enéas de Carvalho Aguiar, 419 - 3o andar
Cerqueira Cesar
São Paulo - SP
CEP 05403-000
Country 11828 0
Brazil
Phone 11828 0
55 (11) 3061-7558
Fax 11828 0
55 (11) 3061-7546
Email 11828 0
[email protected]
Contact person for scientific queries
Name 2756 0
Ruth Natalia Teresa Turrini
Address 2756 0
Av. Dr. Enéas de Carvalho Aguiar, 419 - 3o andar
Cerqueira Cesar
São Paulo - SP
CEP 05403-000
Country 2756 0
Brazil
Phone 2756 0
55 (11) 3061-7558
Fax 2756 0
55 (11) 3061-7546
Email 2756 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.