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

NCT04542928 | Completed

• 1 other identifier: KSPH-2019-17
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Image

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Change in Rosenberg self-Esteem scale (RSES)

  pre-intervention(T0), at 12 weeks (T1) and 16 weeks (T2)

Study Arms (2)

routine care

PLACEBO COMPARATOR

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

Behavioral: nurse facilitated face care group

experimental group

EXPERIMENTAL

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

Behavioral: nurse facilitated face care group

Interventions

nurse facilitated face care group BEHAVIORAL

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

experimental group; routine care

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

Location

Study Officials

• Tu-Lin Lin, BSN

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: September 9, 2020
• Study Start: December 4, 2019
• Primary Completion: July 12, 2020
• Study Completion: July 25, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-07

Locations

TW (1)