SleepNCT04620122
Effects of Progressive Muscle Relaxation Training With Music Therapy on Sleep Quality and Trait Anger/Anger Expression Style of Patients at Community Mental Health Center
A study testing Progressive Muscle Relaxation Training and Music Therapy in people with Sleep and Anger, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep, Anger, Psychiatric Disorder
- What is being tested?
- Progressive Muscle Relaxation Training and Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Community Mental Health Center
Adıyaman, 02100
About this study
Official title: Adiyaman University
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.
- Conditions
- Sleep, Anger, Psychiatric Disorder
- Being tested
- Progressive Muscle Relaxation Training and Music Therapy
- Keywords
- sleep quality, Anger, Psychiatric Disorder, therapy
- Medical subject headings
- Mental Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation Training and Music TherapyOther
Progressive Muscle Relaxation Training and Music Therapy have applied to the participants two sessions for a week during two months.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Progressive Muscle Relaxation Training and Music Therapy are applied to the intervention group. Receives: Other: Progressive Muscle Relaxation Training and Music Therapy |
| control group | No intervention | No intervention is applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyda Başoğul, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620122
- Sponsor's protocol ID
- 2019/4-1
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33639518
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiyaman University
- ClinicalTrials.gov ID
- NCT04620122
- Acronym / sponsor ID
- 2019/4-1
- Conditions
- Sleep, Anger, Psychiatric Disorder
- Keywords
- sleep quality, Anger, Psychiatric Disorder, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Progressive Muscle Relaxation Training and Music TherapyProgressive Muscle Relaxation Training and Music Therapy are applied to the intervention group. |
| control group | No intervention | –No intervention is applied to the control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation Training and Music TherapyProgressive Muscle Relaxation Training and Music Therapy have applied to the participants two sessions for a week during two months. | Other | intervention group |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 minutes
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).
The Trait Anger/Anger Expression Inventory
Time frame: 2 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 33639518Icel 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.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Training and Music Therapy in people with Sleep and Anger, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index (PSQI) (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.