NCT04620122

Brief Summary

Aim: The aim of the study was to examine the effects of progressive muscle relaxation training with music therapy on sleep quality, trait anger, and anger expression style of patients at the community mental health center. Method: The study is conducted as the pretest-posttest control group design. The study population consisted of chronic psychiatric patients who continue in a Community Mental Health Center located in southeastern Turkey. The days when the participants came to the Community Mental Health Center were selected and the participants divided into two groups as an intervention and control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 3, 2020

Last Update Submit

November 3, 2020

Conditions

Keywords

sleep qualityAngerPsychiatric Disordertherapy

Outcome Measures

Primary Outcomes (2)

  • The Pittsburgh Sleep Quality Index (PSQI)

    PSQI is a self-report scale that evaluates sleep quality and disturbance over a one-month period. PSQI was developed by Buysse et al. (1989). The validity and reliability study of PSQI in our country was conducted by Ağargün et al. (1996) (Cronbach's alpha = 0.80).

    2 minutes

  • The Trait Anger/Anger Expression Inventory

    It was developed by Spielberger et al. (1983). Turkish adaptation of the scale was made by Özer and Kadir (1994). The first 10 items of the scale measure trait anger and the next 24 items measure anger expression styles.

    2 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

Progressive Muscle Relaxation Training and Music Therapy are applied to the intervention group.

Other: Progressive Muscle Relaxation Training and Music Therapy

control group

NO INTERVENTION

No intervention is applied to the control group.

Interventions

Progressive Muscle Relaxation Training and Music Therapy have applied to the participants two sessions for a week during two months.

intervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a chronic psychiatric diagnosis according to DSM-V diagnostic criteria,
  • Open and cooperate for communication,
  • living in the city center,
  • age was between 18-60

You may not qualify if:

  • Patients who have just started the Community Mental Health Center
  • patients diagnosed with axis 1,
  • patients diagnosed with mental retardation,
  • patients with drug or alcohol addiction,
  • patients diagnosed with organic brain syndrome,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Mental Health Center

Adıyaman, 02100, Turkey (Türkiye)

Location

Related Publications (1)

  • Icel S, Basogul C. Effects of progressive muscle relaxation training with music therapy on sleep and anger of patients at Community Mental Health Center. Complement Ther Clin Pract. 2021 May;43:101338. doi: 10.1016/j.ctcp.2021.101338. Epub 2021 Feb 19.

MeSH Terms

Conditions

Mental DisordersSleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 6, 2020

Study Start

November 1, 2019

Primary Completion

March 1, 2020

Study Completion

October 30, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations