- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542928
Effectiveness of a Nurse Facilitated Face Care Group in Patients With Schizophrenia
September 7, 2020 updated by: National Yang Ming University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei City, Taiwan
- National Yang-Ming University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: routine care
The controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos.
|
The experimental group is required to receive a nurse leading 50- minute face care group every two week
|
|
Experimental: experimental group
experimental group is required to receive a nurse leading 50- minute face care group every two weeks
|
The experimental group is required to receive a nurse leading 50- minute face care group every two week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
|
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.
|
pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Rosenberg self-Esteem scale (RSES)
Time Frame: pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tu-Lin Lin, BSN, National Yang Ming University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2019
Primary Completion (Actual)
July 12, 2020
Study Completion (Actual)
July 25, 2020
Study Registration Dates
First Submitted
April 19, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (Actual)
September 9, 2020
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSPH-2019-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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