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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: routine care
The controlled group will receive routine functional treatment activities, a facial cleansing instruction and five facial cleansing videos.
Behavioral: nurse facilitated face care group
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
Behavioral: nurse facilitated face care group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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