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Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia

Primary Purpose

Body Image

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
nurse facilitated face care group
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Image

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

routine care

experimental group

Arm Description

The controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos.

experimental group is required to receive a nurse leading 50- minute face care group every two weeks

Outcomes

Primary Outcome Measures

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.
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.
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
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2020
Last Updated
September 7, 2020
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04542928
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
July 12, 2020 (Actual)
Study Completion Date
July 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine care
Arm Type
Placebo Comparator
Arm Description
The controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
experimental group is required to receive a nurse leading 50- minute face care group every two weeks
Intervention Type
Behavioral
Intervention Name(s)
nurse facilitated face care group
Intervention Description
The experimental group is required to receive a nurse leading 50- minute face care group every two week
Primary Outcome Measure Information:
Title
Change in FACE-Q - Appearance-related psychosocial distress
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in FACE-Q - Satisfaction with outcome
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in The Appearance evaluation subscale in MBSRQ
Description
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
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in The Appearance orientation subscale in MBSRQ
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in FACE-Q -Psychological function
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in FACE-Q -Satisfaction with skin
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Title
Change in FACE-Q -Social function
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
Secondary Outcome Measure Information:
Title
Change in Rosenberg self-Esteem scale (RSES)
Description
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.
Time Frame
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tu-Lin Lin, BSN
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia

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