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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542928
Other study ID # KSPH-2019-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2019
Est. completion date July 25, 2020

Study information

Verified date July 2020
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date July 25, 2020
Est. primary completion date July 12, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
nurse facilitated face care group
The experimental group is required to receive a nurse leading 50- minute face care group every two week

Locations

Country Name City State
Taiwan National Yang-Ming University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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 pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Primary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Secondary 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. pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
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