Comparison of diaphragmatic breathing and bulb lining on the anxiety level of patients under hysterectomy
Design
In this study, 126 patients who are referred to Taleghani hospital in Arak and are candidate for hysterectomy are selected. Participants are divided into two intervention groups and a control group using random numbers table and blocking technique. To hide groups from participants, collectors and data analyzers, one code is assigned to each group.
Settings and conduct
This study will be conducted at Taleghani Hospital in Arak.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The presence of benign and malignant gynecological problems;
Being alert after surgery; being hospitalized at least one day before and two days after the surgery.
Exit criteria:
Having another surgery in addition to ovariectomy; Having a history of using breathtaking techniques to control anxiety; Haveing a history of taking sedative, analgesic for more than a month; Need intensive care unit after surgery;Having diseases like psychological disorders, sensory and motor disorders, visual impairment and hearing loss;
Having drug addiction.
Intervention groups
First, the diaphragm breathing technique (DB) is taught to group A and the Pursed Lip Breathing technique (PLB) is taught to group B using simple and intelligible sentences, by face to face individual training.
Individuals in the control group do not receive any intervention from the researcher. Only the researcher will be present at his bed for 20 minutes without giving the patient any education and will fill in the demographic questionnaire and the Spielberger Anxiety Measurement scale. This will be done to reduce the impact of the educator's presence effect on reducing anxiety.
Main outcome variables
Anxiety level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N4
Registration date:2018-06-05, 1397/03/15
Registration timing:registered_while_recruiting
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of diaphragmatic and pursed lip breathing on the anxiety of patients undergoing hysterectomy surgery
Public title
The effect of diaphragmatic pursed lip breathing on the anxiety of hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of benign and malignant gynecological problems
Being alert after surgery
being hospitalized at least one day before and two days after the surgery
Patient Satisfaction to Participate in Research
Exclusion criteria:
Having another surgery in addition to ovariectomy
Having a history of using breathtaking techniques to control anxiety
Haveing a history of taking sedative, analgesic or antianxiety drugs for more than a month
Incidence of surgical complications such as severe bleeding, acute infection and hospitalization in intensive care unit
Having diseases like psychological disorders, sensory and motor disorders, visual impairment and hearing loss
Having drug addiction
Age
From 20 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization was used. Random numbers table was used to determine the blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Individuals in one group are unaware of the type of intervention in other groups. Also, the person who collects data for each group is unaware of the intervention of other groups. The data analyzer will be unaware of the type of intervention assigned to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.ARAKMU.REC.1396.168
Health conditions studied
1
Description of health condition studied
ANEXITY
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of anxiety
Timepoint
Measurement of the anxiety level at the night before surgery, half an hour before the surgery, and after full vigilance after surgery
Intervention group 1: First, diaphragmatic breathing (DB) is taught to patients using simple and intelligible sentences through individualized face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery.Diaphragmatic breathing technique is as follows: Patient lies in a comfortable position on the back. Then, puts one hand on the chest and the other hand on the abdomen. In this position, patient exhales somehow, the hand on the abdomen to be pulled forward while pushing in and brings out the air from lungs slowly. During the expiration, holds the hand on the chest in the same condition.
Category
Treatment - Other
2
Description
Intervention group 2: First, pursed lip breathing (PLB) is taught to patients using simple and intelligible sentences through individual face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery. Breathing technique: The patient sits in a comfortable position and closes his/her mouth and breathes a deep breath through the nose and with the lips of the bud (whistling mode) exhales air through the mouth. The patient should breathe so that expiration time (exhale through the mouth) will be twice of the inspiration time (inhale air through the nose). That means inspiration time will be 2 seconds and expiration time will be 4 seconds.
Category
Treatment - Other
3
Description
Control group: Individuals in the control group do not receive any intervention. Only the researcher will be present at the bedside for 20 minutes without giving the education to the patient and will fill in the demographic questionnaire and the Spielberger anxiety test. This action will be done to remove the effect of the researcher's presence.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
1- Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD