Body ImageNCT04542928
Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia
A study testing nurse facilitated face care group in people with Body Image, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study aims to explore the effectiveness of nurse-facilitated face care group on body image and self-esteem in female patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Body Image
- What is being tested?
- nurse facilitated face care group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2019to 25 Jul 2020
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with Schizophrenia and schizoaffective disorder for more than two years.
- The age is above 20 year.
- Can communicate with Mandarin or Taiwanese.
- The score of the Positive and Negative Syndrome Scale(PANSS) is below 60(included).
- People are willing to participate in this study, can read and know the consent and can sign on the consent by their own.
Who cannot join
- Exclude people with a personality disorder, brain injury, cognitive impairment, Intellectual Developmental Disorder or substance use disorder.
- people who are not willing to sign the consent.
- people can not read.
- people can not communicate with Mandarin or Taiwanese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia：A Randomized Controlled Trial
This study aims to explore the effectiveness of nurse-facilitated face care group on body image and self-esteem in female patients with schizophrenia.
Read the detailed description
Many studies have shown that patients with schizophrenia have poor cleanliness and negligible appearance, which leads to negative body image and low self-esteem. However, there are few researches in Taiwan that nurse facilitated face care group in patients with schizophrenia to improve their body image and self-esteem.This study was to explore the effectiveness of a nurse facilitated face care group in patients with schizophrenia in improving their body image and self-esteem.A total of 96 patients with schizophrenia in a mental hospital in southern Taiwan were recruited in this study. The participants were divided into experimental and control groups through block randomization. In addition to participating in routine functional treatment activities, the experimental group is required to receive an additional 50 minutes of face care grou every two weeks led by the nurse. The patients in control group received routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos. The research tools include demographic data, the subscale in MBSRQ - Appearance evaluation and Appearance orientation, FACE-Q - Appearance-related psychosocial distress. FACE-Q - Satisfaction with outcome. FACE-Q - Psychological function. FACE-Q - Satisfaction with skin. FACE-Q - Social function. Rosenberg self-Esteem scale (RSES). A questionnaire survey of body image and self-esteem was conducted before the intervention, 12 weeks after the intervention and one month after the end of the intervention.The collected data were analyzed by IBM SPSS 24.0 statistical software. The descriptive statistics include mean, minimum, maximum, standard deviation, frequency distribution, and percentages; the Generalized estimating equation (GEE) were employed to explore the effectiveness of a nurse facilitated face care group in patients with schizophrenia after controlling demographic data.
- Conditions
- Body Image
- Being tested
- nurse facilitated face care group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse facilitated face care groupBehavioural
The experimental group is required to receive a nurse leading 50- minute face care group every two week
| Study group | Role | What they receive |
|---|---|---|
| routine care | Placebo comparator | The controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos. Receives: Behavioral: nurse facilitated face care group |
| experimental group | Experimental | experimental group is required to receive a nurse leading 50- minute face care group every two weeks Receives: Behavioral: nurse facilitated face care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FACE-Q - Appearance-related psychosocial distress
To measure the level of Appearance-related psychosocial distress.There are 8 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more appearance-related psychosocial distress.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in FACE-Q - Satisfaction with outcome
To measure satisfaction with outcome.There are 6 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more satisfaction with outcome.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in The Appearance evaluation subscale in MBSRQ
To measure the attractiveness or lack of attractiveness of an individual's physical appearance, a person's satisfaction or dissatisfaction with his appearance.There are 7 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=neither agree nor disagreeagree, 4=agree, 5=strongly agree).Higher scores reflect more satisfied you are with your appearance
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in The Appearance orientation subscale in MBSRQ
To assess how much the individual attaches importance to appearance.There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=neither agree nor disagreeagree, 4=agree, 5=strongly agree).Higher scores reflect more you care about your appearance.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in FACE-Q -Psychological function
To measure psychological function.There are 10 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect higher psychological function.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in FACE-Q -Satisfaction with skin
To measure satisfaction with skin.There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more satisfaction with skin.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Change in FACE-Q -Social function
To measure satisfaction with skin.There are 8 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect higher social function.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Secondary outcomes (1)
Change in Rosenberg self-Esteem scale (RSES)
To measure the level of self-esteem.There are 10 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher level of self-esteem.
Measured: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start4 Dec 2019
- Primary completion12 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu-Lin Lin, BSN, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542928
- Sponsor's protocol ID
- KSPH-2019-17
- Status last verified
- Jul 2020
- First submitted
- 19 Apr 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04542928
- Acronym / sponsor ID
- KSPH-2019-17
- Conditions
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 9 Sep 2020 (actual)
- 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.
This study aims to explore the effectiveness of nurse-facilitated face care group on body image and self-esteem in female patients with schizophrenia.
Detailed description
Many studies have shown that patients with schizophrenia have poor cleanliness and negligible appearance, which leads to negative body image and low self-esteem. However, there are few researches in Taiwan that nurse facilitated face care group in patients with schizophrenia to improve their body image and self-esteem.This study was to explore the effectiveness of a nurse facilitated face care group in patients with schizophrenia in improving their body image and self-esteem.A total of 96 patients with schizophrenia in a mental hospital in southern Taiwan were recruited in this study. The participants were divided into experimental and control groups through block randomization. In addition to participating in routine functional treatment activities, the experimental group is required to receive an additional 50 minutes of face care grou every two weeks led by the nurse. The patients in control group received routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos. The research tools include demographic data, the subscale in MBSRQ - Appearance evaluation and Appearance orientation, FACE-Q - Appearance-related psychosocial distress. FACE-Q - Satisfaction with outcome. FACE-Q - Psychological function. FACE-Q - Satisfaction with skin. FACE-Q - Social function. Rosenberg self-Esteem scale (RSES). A questionnaire survey of body image and self-esteem was conducted before the intervention, 12 weeks after the intervention and one month after the end of the intervention.The collected data were analyzed by IBM SPSS 24.0 statistical software. The descriptive statistics include mean, minimum, maximum, standard deviation, frequency distribution, and percentages; the Generalized estimating equation (GEE) were employed to explore the effectiveness of a nurse facilitated face care group in patients with schizophrenia after controlling demographic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine care | Placebo comparator | Behavioral: nurse facilitated face care groupThe controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos. |
| experimental group | Experimental | Behavioral: nurse facilitated face care groupexperimental group is required to receive a nurse leading 50- minute face care group every two weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with Schizophrenia and schizoaffective disorder for more than two years.
- The age is above 20 year.
- Can communicate with Mandarin or Taiwanese.
- The score of the Positive and Negative Syndrome Scale(PANSS) is below 60(included).
- People are willing to participate in this study, can read and know the consent and can sign on the consent by their own.
Key exclusion criteria (4 listed)
- Exclude people with a personality disorder, brain injury, cognitive impairment, Intellectual Developmental Disorder or substance use disorder.
- people who are not willing to sign the consent.
- people can not read.
- people can not communicate with Mandarin or Taiwanese.
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 |
|---|---|---|
| nurse facilitated face care groupThe experimental group is required to receive a nurse leading 50- minute face care group every two week | Behavioural | experimental group, routine care |
Primary outcome
Change in FACE-Q - Appearance-related psychosocial distress
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure the level of Appearance-related psychosocial distress.There are 8 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more appearance-related psychosocial distress.
Change in FACE-Q - Satisfaction with outcome
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure satisfaction with outcome.There are 6 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more satisfaction with outcome.
Change in The Appearance evaluation subscale in MBSRQ
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure the attractiveness or lack of attractiveness of an individual's physical appearance, a person's satisfaction or dissatisfaction with his appearance.There are 7 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=neither agree nor disagreeagree, 4=agree, 5=strongly agree).Higher scores reflect more satisfied you are with your appearance
Change in The Appearance orientation subscale in MBSRQ
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To assess how much the individual attaches importance to appearance.There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=neither agree nor disagreeagree, 4=agree, 5=strongly agree).Higher scores reflect more you care about your appearance.
Change in FACE-Q -Psychological function
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure psychological function.There are 10 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect higher psychological function.
Change in FACE-Q -Satisfaction with skin
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure satisfaction with skin.There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect more satisfaction with skin.
Change in FACE-Q -Social function
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
To measure satisfaction with skin.There are 8 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree).Higher scores reflect higher social function.
1 secondary outcome
Change in Rosenberg self-Esteem scale (RSES)
Time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
Tu-Lin Lin, BSN principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse facilitated face care group in people with Body Image, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2020. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in FACE-Q - Appearance-related psychosocial distress (time frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)). The study lists 7 primary outcomes in all. 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 Sep 2020.