Clinical trial NCT04542928: Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia
Official title: Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 97
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in FACE-Q - Appearance-related psychosocial distress
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in FACE-Q - Satisfaction with outcome
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in The Appearance evaluation subscale in MBSRQ
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in The Appearance orientation subscale in MBSRQ
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in FACE-Q -Psychological function
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in FACE-Q -Satisfaction with skin
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
measure: Change in FACE-Q -Social function
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Secondary outcomes:
measure: Change in Rosenberg self-Esteem scale (RSES)
timeFrame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Tu-Lin Lin, BSN
role: PRINCIPAL_INVESTIGATOR
References: