1) The objective of present study is Comparing the effect of Benson relaxation and nature sound on anxiety and fatigue of the patients with heart failure 2) Design: The study is a randomized clinical trial with both control and intervention group 3) Setting and conduct: 105 patients with heart failure admitted in the CCU of Imam Reza (AS) and Fatima (SA) hospitals will be randomly placed in the intervention and control groups. 4) Participants including major eligibility criteria: They are patients with heart failure 5) Intervention: The intervention group will be trained Benson musle relaxation. In Benson muscle relaxation with headphones for 20 minutes twice a day, morning and evening during of 3 days they perform relaxation. In the intervention group the sounds of nature, nature sounds through headphones patients 2 times a day for 20 minutes each morning and evening during 3 days listening. The control group did not receive anything 6) Main outcome measures: The primary outcomes variable are anxiety and fatigue.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121425528N1
Registration date:2016-03-09, 1394/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Leila Seifi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
seifi.l@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran university of medical science
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Benson relaxation and nature sound on anxiety and fatigue of the patients with heart failure
Public title
Comparing the effect of Benson relaxation and nature sound on anxiety and fatigue of the patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: The diagnosis of heart failure by a doctor ؛ An ejection fraction less than35% ؛ Patient said the fatigue and anxiety؛ Alert and able to collaborate with researchers؛ Lack of cognitive and mental disorders؛ Lack of neuromuscular disorders؛ Lack of addiction to drugs- sedatives and alcohol؛ No history of relaxation methods. Exclusion criteria: Patients who do not tolerate intervention؛ After education and investigation of procedure ability if they do not learn relaxation skills؛ With acute situation(Connecting to ventilator)؛ They die during the intervention
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences and health services
Street address
Iran university of medical sciences, Shahid Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.IUMS.rec.1394.9311449002
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure Cardiac asthma Left heart failure Oedema of lung Pulmonary oedema
Primary outcomes
1
Description
Anxiety
Timepoint
Before and immediately after the intervention
Method of measurement
Speilberger Anxiety questionnaire
2
Description
Fatigue
Timepoint
One day before, The third day after the intervention
Method of measurement
Fatigue Severity Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this group, patients listen to a nature sounds by headphone a like waterfalls, the sound of rain ,birds,etc twice in each day in 20 minutes ,2times for 3 days.
Category
Rehabilitation
2
Description
In the intervention group of Benson muscle relaxation, patients received twice a day ،morning and evening for three days. In this method ,moreover the patients listen to a relaxation CD, they relax their muscle from toe to muscles of upper body .
Category
Rehabilitation
3
Description
Routin procedures are done for the control group only ,the patient had not received intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Leila Seifi
Street address
Emam Reza st, Emam Reza hospital, Amol
City
Amol
2
Recruitment center
Name of recruitment center
Fatemeh Zahra hospital
Full name of responsible person
Leila Seifi
Street address
Emam KHomeini Square, Jam-e Jam St, Fateme Zahra hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran university of medical science
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Iran university of medical sciences, Shahid Hemmat highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of nursing & midwifery of Iran university
Full name of responsible person
Leila Seifi
Position
Post graduate student in nursing
Other areas of specialty/work
Street address
School of nursing & midwifery, Rashid Yasemi St, Valiasr St, Tehran
City
Tehran
Postal code
Iran
Phone
+98 21 8888 2886
Fax
Email
mitraseifimehr@yahoo.com; seifi.l@tak.iums .ac.ir
Web page address
mitraseifimehr@yahoo.com; seifi.l@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing & midwifery of Iran university
Full name of responsible person
Tahere Najafi
Position
Ph.D in nursing
Other areas of specialty/work
Street address
School of nursing & midwifery, Rashid Yasemi st, (after Vanak square), Vali-e- Asr st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
najafi.t@iums.ac .ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of nursing & midwifery of Iran university
Full name of responsible person
Leila Seifi
Position
Post graduate student in nursing
Other areas of specialty/work
Street address
School of nursing & midwifery, Rashid Yasemi St, (after Vanak square ), Vali-e-Asr st, Tehran, Iran
City
Tehran
Postal code
Iran
Phone
+98 21 8888 2886
Fax
Email
mitraseifimehr@yahoo.com; seifi.l@tak.iums. ac .ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)