A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention

NCT05012709 | Completed

• 1 other identifier: JiananPsych
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT). Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa. The CONSORT checklist for RCT was reported. Psychotic symptoms, emotional reactions, behavioral relaxation responses and heart rates were assessed at 6 time points.

Conditions

Psychotic Disorders; Anxiety; Complementary Therapies; Clinical Trial

Outcome Measures

Primary Outcomes (4)

• Change of Psychiatric Symptoms

  Brief Psychiatric Rating Scale (BPRS) consists of a series of 18 items that are used to assess the following psychotic symptoms: somatic concern, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement, and disorientation (Overall and Gorham, 1962). The total score range is between 0 (not present) and 18 (extremely severe). The reliability of BPRS in this study was acceptable (Cronbach's α = 0.71).

  Change from baseline BPRS at the sixth sessions (each session is 7 days).

• Change of Anxiety

  The Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) includes seven items. Each item is evaluated on a four-point (0 to 3) scale, with a total possible score range of 0 to 21. Scores of eight and higher indicate the possible presence of anxiety. The reliability of HADS-A in this study was acceptable (Cronbach's α = 0.67).

  Change from baseline HADS-A at the sixth sessions (each session is 7 days).

• Change of Behavioral Relaxation

  Behavioral Relaxation Scale (BRS) was administered to measure the motor elements of relaxation through observations of voluntary muscles by trained clinicians. Ten dimensions of postures were observed (e.g. breath, shoulders, hands… etc.) and behaviors were checked for indications of relaxation. The total score range of the BRS is between 0 (no relaxation) and 10 (relaxation).

  Change from baseline BRS at the sixth sessions (each session is 7 days).

• Change of physiological responses

  Patients' Heart Rate, as an indicator of their responses to stress and tension, was measured by a wireless biofeedback system (MindMedia, Herten). The data was collected at a rate of 400 importing signals every minute.

  Change from baseline heart rate at the sixth sessions (each session is 7 days).

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on.

Behavioral: multisensory stimulation therapy

control group

NO INTERVENTION

The TAU group received usual routine care.

Interventions

multisensory stimulation therapy BEHAVIORAL

The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on.

intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized patients
• diagnosed with schizophrenia, schizophreniform disorder, and schizoaffective disorder for more than 5 years according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association, 2013).
• aged above 20 years old

You may not qualify if:

• had a history of alcohol and drug abuse
• could not concentrate on activities for at least 30 minutes.

Sponsors & Collaborators

• Jianan Psychiatric Center, Ministry of Health and Welfare: lead
• Taiwan Nurses Association: collaborator
• National Cheng Kung University: collaborator

Study Sites (1)

Mei-Feng, Lin

Tainan, 70101, Taiwan

Location

Related Publications (7)

• American Psychiatric Association. (2013). Quick reference to the diagnostic criteria from DSM-V (p. 370). Washington, DC: APA.

  BACKGROUND

• Overall, J. E., & Gorham, D. R. (1962). The brief psychiatric rating scale. Psychological reports, 10(3), 799-812. https://doi.org/10.2466%2Fpr0.1962.10.3.799

  BACKGROUND

• Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

  PMID: 12914662 BACKGROUND

• Michultka DM, Poppen RL, Blanchard EB. Relaxation training as a treatment for chronic headaches in an individual having severe developmental disabilities. Biofeedback Self Regul. 1988 Sep;13(3):257-66. doi: 10.1007/BF00999174.

  PMID: 3067751 BACKGROUND

• Cheng SC, Hsu WS, Shen SH, Hsu MC, Lin MF. Dose-Response Relationships of Multisensory Intervention on Hospitalized Patients With Chronic Schizophrenia. J Nurs Res. 2017 Feb;25(1):13-20. doi: 10.1097/jnr.0000000000000154.

  PMID: 27310606 BACKGROUND

• Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.

  PMID: 31012939 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.

  PMID: 20334632 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Mei-Feng Lin, PhD

  National Cheng Kung University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, Professor, Department of Nursing, College of Medicine, National Cheng Kung University

Model Details: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 19, 2021
• Study Start: March 15, 2012
• Primary Completion: January 10, 2013
• Study Completion: March 10, 2013
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)