The aim of this study was to determine the effect of breathing intervention on the anxiety and physiological parameters of hemodialysis patients. This study was a single-blind clinical trial. This study was performed on chronic renal failure patients undergoing hemodialysis, referring to hemodialysis department of Hajar hospital in Shahrekord, in 1396. Sampling was available. 100 hemodialysis patients had inclusion criteria. These patients were divided into two groups of 50. Sampling was done randomly. Sampling was done on pairs days. Control group sampling was done on individual days. The experimental group performed breathing intervention (deep breathing) for eight sessions in a month and under the guidance of a nurse. The control group received usual care. The research instrument was a three-part questionnaire (demographic information, Spielberger's State-Trait Anxiety and physiological parameters (systolic and diastolic blood pressure, heart rate and respiratory rate) by interventional questionnaire, ten minutes before and ten minutes later The intervention was completed by interviewing. Inclusion criteria: a chronic kidney disease under hemodialysis two or three sessions a week. The age of the participants was 18 years and older. The participants should have the following conditions:
Absence of hearing impairment
Under hemodialysis for more than three months
The absence of psychiatric disorders approved by the psychiatrist
Lack of underlying illness of the respiratory system that makes it difficult for the patient to perform breathing exercises.
The desire to participate in the study.
Exclusion criteria:
Hospital admission to hospital for any reason.
Lack of regular referral for dialysis during the course of the study.
Patient death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100736611N1
Registration date:2017-11-15, 1396/08/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Fatemeh Seife
Name of organization / entity
Faculty of Nursing, University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33383586
Email address
st-seife.f@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-06-07, 1396/03/17
Expected recruitment end date
2017-07-08, 1396/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing intervention on anxiety and physiological parameters of hemodialysis patients
Public title
The effect of breathing intervention on anxiety and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Chronic kidney disease and hemodialysis, two or three sessions, per week; age 18 and above; non-acute hearing impairment; hemodialysis for more than three months; lack of mental disorders confirmed by a psychiatrist; It lacks the underlying condition of the respiratory system that makes it difficult for the patient to perform breathing exercises and tends to participate in the study. (Exclusion criteria: if the patient is hospitalized for any reason; absence of regular referral for dialysis during the study period; patient's death).
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Shahrekord University of Medical Sciences
Street address
Research Deputy, University of Medical Sciences, Kashani Street , Shahrekord
City
Shahrekord
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
(IR.SKUMS.REC1396.56)
Health conditions studied
1
Description of health condition studied
Chronic kidney disease - hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Situational anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger's State-Trait Anxiety Questionnaire
2
Description
Physiological parameters
Timepoint
Before and after intervention
Method of measurement
Blood pressure in mm of mercury Medical barometer and Stethoscope and radial pulse rate measurement and breathing rate for one minute
Secondary outcomes
empty
Intervention groups
1
Description
This is a single-blind clinical trial that was done In the experimental group, these exercises were performed in 3 stages. The nurse's guidance was performed in three ways and in three stages as follows:
1) Respiratory training was provided to nurses individually (face to face) for 10 minutes.
2) The instructions for the respiratory program (adequate abdominal respiration, respiratory rate, body condition, and abdominal contraction and expansion along the tail and exhalation) were broadcast through the audio device for 10 minutes. Then, in the music background, the patients with the speaker's guidance Or the nurse (2, 3, 4 and breath 2, 3, 4, and breath .....) breathed deeply and slowly.
3) In the next step, the patients performed respiratory exercises under direct guidance of the nurse for 30 minutes (2).
At the first session, all three stages were supervised by the nurse. In the next sessions of the last stage, it was done by the nurse's indirect care for breathing exercises. Of course, at each training session, the nurse should make sure that the patient learned the exercises and performed properly. Also, the patient did not sleep during the training.
Category
Treatment - Other
2
Description
The control group received usual care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital Affiliated to Shah-re-kord University of Medical Sciences
Full name of responsible person
Fatemeh Seifi Critical Care Nursing MSc Student
Street address
Mahdi Complex Unit 6, Alley 27, Bozorgmehr Street, Mirabad, Shah-re-kord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord Medical Sciences University
Full name of responsible person
Dr. Ali Hassanpour
Street address
Research Deputy, University of Mdical Sciences, Kasehani Street, Shah-re-kord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord Medical Sciences University
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, Shahrekord University of Medical Sciences
Full name of responsible person
fatemeh seife
Position
Critical Care Nursing (MSc) Student
Other areas of specialty/work
Street address
Mahdi Complex Unit 6, Alley 27, Bozorgmehr Street, Mirabad, Shah-re-kord
City
Shahrekord
Postal code
Phone
+98 38 3338 3586
Fax
Email
st-seife.f@skums.ac.ir; fatemeh.seife@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing, University of Medical Sciences
Full name of responsible person
fatemeh aliakbari
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Somayeh Avenue, Teachers Street, Shahr-e-Kord
City
Shahrekord
Postal code
Phone
+98 38 3333 5648
Fax
Email
aliakbari.f@skums.ac.ir; aliakbarifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing, University of Medical Sciences
Full name of responsible person
Fatemeh Seife
Position
Critical Care Nursing (MSc) Student
Other areas of specialty/work
Street address
Mahdi Complex Unit 6, Alley 27, Bozorgmehr Street, Mirabad, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3338 3586
Fax
Email
st-seife.f@skums.ac.ir; fatemeh.seife@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)