"Hematologic Diseases"NCT01718002
Effect of the Use of Simulation (Video) on the Oral Hygiene
A study testing Educational video in people with "Hematologic Diseases", run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The care of the oral cavity is an important way to prevent local and systemic infections. This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy. The methodological design used was quasi-experimental before-after intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- "Hematologic Diseases"
- What is being tested?
- Educational video
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical conditions for self-care during the oral hygiene;
- Score less than or equal to three according to scale performance general condition was drafted and approved by the American Eastern Cooperative Oncology Group (ECOG)
- Accept oral diet
- Lack of nasal catheter or probe nasogastric and nasoenteric
- Present platelet counts > 20,000 mm3
- Neutrophils > 1,000 mm3
- Absence of pathologies or buccal devices which prevent attainment the procedure
- The presence of teeth
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Use of Simulation (Video) on the Oral Hygiene of People Undergoing Chemotherapy
The care of the oral cavity is an important way to prevent local and systemic infections. This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy. The methodological design used was quasi-experimental before-after intervention. The sample consisted of 23 subjects who performed the technique of oral hygiene before and after watching an educational video. To do so was given a kit with a toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test t "Student" paired.
Read the detailed description
General Purpose Evaluating the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.
Specific Objectives Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene; To investigate the effect of an educational video on oral hygiene in this clientele; Identify patient acceptance of the teaching method employed.
Methods and Procedures Delineation The research was quasi-experimental in nature, before-after intervention (the intervention in this study was the teaching learning strategy employed used an educational video on oral hygiene.) Patients will be evaluated individually, before and after exposure to video. It is not foreseen monitoring at other times.
- Conditions
- "Hematologic Diseases"
- Being tested
- Educational video
- Keywords
- Nursing, Simulation, Education
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.
| Study group | Role | What they receive |
|---|---|---|
| Educational video on oral hygiene | Other | The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially. Receives: Behavioral: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video as a teaching strategy
Evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.
The subjects were asked to assign a note about the importance of oral hygiene on a scale of zero to 10.
Measured: 18/11/2011 to 30/06/2012
Secondary outcomes (3)
Oral hygiene before (initial performance) and after (final performance) exposure to an educational
Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene. The subjects were assessed for scores of hits in 15 steps related to the process of oral hygiene before and after the presentation of educational video. he steps are related to the amount of cream dents, tilt the brush, brushing locations, movements employees, number of repetitions, use of dental floss, mouthwash, among others. Eg: P1 - applied a small amount of toothpaste on the brush; P2 - put the brush bristles inclined in place, between the gum and the tooth, put the brush bristles inclined in place, between the gum and the tooth; P3 - brushed the upper arch with sweeping movements towards the top down; P4 - brushed with the lower jaw movements sweep from top to bottom; P5 - brushed the inside of the teeth gum toward the tip of the tooth, using the movement "sweep "...
Measured: 18/11/2011 to 30/06/2012
Effect of an educational video
To investigate the effect of an educational video on oral hygiene in this clientele.
As for settling scores of the 15 items assessed (maximum score 15) in the implementation of oral hygiene procedure, the subjects had an average initial phase in the other end. We used the t test "Student" test to detect differences between these averages
Measured: 18/11/2011 to 30/06/2012
Acceptance of the teaching method
Identify patient acceptance of the teaching method employed. When the relevance of experience to learn by watching the video, subjects were asked to assign a grade on a scale of zero to 10. From this note will be calculated averages and standard deviation.
Measured: 18/11/2011 to 30/06/2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for "Hematologic Diseases"Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Campos de Carvalho, University of Sao Paulo
- Investigators
- Emilia C Carvalho, Principal investigator, Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo - EERP-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718002
- Sponsor's protocol ID
- Lab. Comunicação EERP
- Status last verified
- Nov 2012
- First submitted
- 28 Oct 2012
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Simulation (Video) on the Oral Hygiene of People Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT01718002
- Acronym / sponsor ID
- Lab. Comunicação EERP
- Conditions
- "Hematologic Diseases"
- Keywords
- Nursing, Simulation, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The care of the oral cavity is an important way to prevent local and systemic infections. This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy. The methodological design used was quasi-experimental before-after intervention. The sample consisted of 23 subjects who performed the technique of oral hygiene before and after watching an educational video. To do so was given a kit with a toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test t "Student" paired.
Detailed description
General Purpose Evaluating the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.
Specific Objectives Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene; To investigate the effect of an educational video on oral hygiene in this clientele; Identify patient acceptance of the teaching method employed.
Methods and Procedures Delineation The research was quasi-experimental in nature, before-after intervention (the intervention in this study was the teaching learning strategy employed used an educational video on oral hygiene.) Patients will be evaluated individually, before and after exposure to video. It is not foreseen monitoring at other times.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational video on oral hygiene | Other | Behavioral: Educational videoThe patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Physical conditions for self-care during the oral hygiene;
- Score less than or equal to three according to scale performance general condition was drafted and approved by the American Eastern Cooperative Oncology Group (ECOG)
- Accept oral diet
- Lack of nasal catheter or probe nasogastric and nasoenteric
- Present platelet counts > 20,000 mm3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoThe patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially. | Behavioural | Educational video on oral hygiene |
Primary outcome
Video as a teaching strategy
Time frame: 18/11/2011 to 30/06/2012
Evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy. The subjects were asked to assign a note about the importance of oral hygiene on a scale of zero to 10.
3 secondary outcomes
Oral hygiene before (initial performance) and after (final performance) exposure to an educational
Time frame: 18/11/2011 to 30/06/2012
Effect of an educational video
Time frame: 18/11/2011 to 30/06/2012
Acceptance of the teaching method
Time frame: 18/11/2011 to 30/06/2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia C Carvalho principal investigator
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo - EERP-USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with "Hematologic Diseases", run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video as a teaching strategy (time frame: 18/11/2011 to 30/06/2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.