To investigate the effect of Solar plexus reflexology of sole of the foot on pain, anxiety and physiological Indicators caused by bone marrow aspiration (BMA) in patients with leukemia
In this study, the effect of reflexology of sole of the foot reflex points on pain, anxiety and physiological parameters of bone marrow aspiration in patients with leukemia was investigated.
Design
In this clinical trial study, 70 patients who admitted to the oncology hospital and have eligible inclusion in the study are randomly divided into three groups of intervention and control.
Settings and conduct
Massage intervention in the intervention group, takes place 10 minutes after bone marrow aspiration procedure by using 10 ml of olive oil for 15 minutes for each patient's foot in the reflection points of the sole of the foot (solar plexus, pituitary and spine).
To measure the main outcome variables of the study, 5 minutes before and immediately before the intervention were determined and the average of these two measurements as a score before the intervention is recorded.
Also, the average of the measurements immediately after the intervention and 5 minutes after the intervention is considered as the score after the intervention. Research units are selected from patients with leukemia hospitalized in Ayatollah Khansari Hospital in Arak.
Participants/Inclusion and exclusion criteria
entry conditions: 1) Leukemia 2) Age range 18 to 60 years 3) Perform bone marrow aspiration for the first time.
No entry conditions: 1) Previous experience or awareness of the impact of acupressure 2) Lack of full consciousness, having mental, visual and auditory disorders 3) History of taking anti-anxiety and sedative drugs before the study
Intervention groups
Intervention groups: Intervention group: Reflexology intervention in the reflection points of the sole of the foot (solar plexus, pituitary and spine) for 15 minutes for each foot; Control group: no intervention
To investigate the effect of Solar plexus reflexology of sole of the foot on pain, anxiety and physiological Indicators caused by bone marrow aspiration (BMA) in patients with leukemia
Public title
To investigate the effect of Solar plexus reflexology of sole of the foot on pain, anxiety and physiological Indicators caused by bone marrow aspiration (BMA) in patients with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Catching leukemia (lymphoblastic or Myeloblastic)
The age range of 18 to 60
Signature of informed consent form
do bone marrow aspiration for the first time
Have literacy to complete the questionnaire
Exclusion criteria:
Previous experience or awareness of the impact of acupressure
Lack of full consciousness, having mental, visual and auditory disorders
History of taking anti-anxiety and sedative drugs one week before participating in the study (based on the contents of the file)
Drug addiction
Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)
Existence of sensory and motor disorders in the legs and minimal ability to walk on the legs (peripheral neuropathy or vascular problems in the lower extremities)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in an accessible (easy) method among all patients with leukemia (lymphoblastic or myeloblastic) who need bone marrow aspiration hospitalized in Ayatollah Khansari Hospital in Arak. Patients with equal number of members (1: 1) are randomly assigned to each of the intervention and control groups. Due to the gradual entry of samples into the research in this research, random allocation is done by a random sequence method by a table of random numbers in Excel software. To avoid the bias of random selection of individuals to study groups, it is hidden and this sequence remains hidden until the intervention. For this purpose, consecutive dark and numbered envelopes are used to enclose the sequences.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blind groups in this study include patients, an assistant research data collector, and a statistician; In such a way that none of the patients and also the data collector was aware of the allocation of patients to the two intervention and control groups and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, Will be analyzed. (Explanation: In this study, the person collecting information is different from the person performing the intervention).
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
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.ARAKMU.REC.1400.111
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
2
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
3
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
4
Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, immediately before intervention and after intervention
Method of measurement
The State-Trait Anxiety Inventory -Spielberger
2
Description
Pain
Timepoint
Before intervention, immediately before intervention and after intervention
Method of measurement
Numeric pain rating scale (NRS)
3
Description
Heart beat
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Number of beats per minute - pulse oximeter
4
Description
Arterial blood oxygen saturation (SPO2)
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Percentage - pulse oximeter
5
Description
Respiratory rate
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Count per minute - count breathing by observation
6
Description
Blood pressure
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
By sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 10 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the left foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. 5 minutes is for general massage of the sole of the foot and the next 10 minutes is for the relief of pain and anxiety caused by the procedure in the reflection points of the sole of the foot (points of the solar plexus, pituitary and spine). Then the same steps are performed on the patient's right foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague.
Category
Treatment - Other
2
Description
Control group: There is no special intervention in the control group and these patients receive only routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Ali Safdari
Street address
NO. Hospital Ayatollah khansari , End of University Avenue , arak , Central Province
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
asafdari.nu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliraza Kamali
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com
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
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Member of Arak Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
razieh.mokhtari91@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Shared data include demographic information of participants' patients, type and method of intervention, information about anxiety, pain and physiological indicators of participants before and after the intervention.
When the data will become available and for how long
Start the access period 6 months after the results are published.
To whom data/document is available
Researchers and people working in nursing as well as people working in clinical nursing
Under which criteria data/document could be used
The obtained data can be used for education, research and clinic of nursing. The applicant must be in the field of nursing. The data applicant should use the data only for education, research and clinic of nursing.
From where data/document is obtainable
Ali Safdari, Department of critical care nursing, school of nursing, Arak university of medical sciences E mail:asafdari.nu@gmail.com
What processes are involved for a request to access data/document
After confirming that the data requester is in the field of nursing, the type of request will be answered immediately via email.