The ٍEffects of Foot Reflexology on the Incidence of Delirium, Sleep Disorder and Pain in Patients after Open Heart Surgery in Baghiatollah and Jamaran Hospital in 2017 and 2018
The Effect of Foot Reflexology Massage on the Incidence of Delirium, Pain and Sleep Disorders in Patients after Open Heart Surgery
Design
This ُStudy is a Clinical Trial Study with a Control Group with Parallel Groups
Settings and conduct
Includes all patients admitted to Baqiyatallah and Jamaran hospitals for open heart surgery and transferred to intensive care unit after open heart surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: open heart surgery for first time; non emergency open heart surgery; healthy foot.
Exclusion criteria: opium addiction; severe hearing impairment; existential psychological problems.
Intervention groups
In the experimental group after open heart surgery and transfer to the intensive care unit and 2 hours after the patient's removal from mechanical ventilation, the first session of massage therapy and the second session will be performed the next day after surgery. The Questionnaires were completed on the first and second morning after surgery. In the control group the questionnaires were completed without the intervention on the first and second days after surgery.
Main outcome variables
Delirium, sleep disorder, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190719044268N1
Registration date:2020-01-23, 1398/11/03
Registration timing:retrospective
Last update:2020-01-23, 1398/11/03
Update count:0
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
Ahmad Fazlolah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 5665
Email address
t_moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2018-10-07, 1397/07/15
Actual recruitment end date
2019-05-21, 1398/02/31
Trial completion date
2019-06-21, 1398/03/31
Scientific title
The ٍEffects of Foot Reflexology on the Incidence of Delirium, Sleep Disorder and Pain in Patients after Open Heart Surgery in Baghiatollah and Jamaran Hospital in 2017 and 2018
Public title
Effects of Foot Reflexology on the Incidence of Delirium, Sleep Disorder and Pain in Patients after Open Heart Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Open heart Surgery for First Time
Non Emergency Open Heart Surgery
Healthy Foot
Exclusion criteria:
Opium Addiction
Severe Hearing Impairment.
Existential Psychological Problems.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned to Experimental and Control Groups using four blocks Method.
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
Baqiyatollah University of Medical Science
Street address
Baqiyatollah University of Medical Sciences, Sheikh Bahaei St, Molla Sadra St, Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.BMSU.REC.1397.023
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Sleep Disorder
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
3
Description of health condition studied
Pain
ICD-10 code
F45.4
ICD-10 code description
Pain disorders related to psychological factors
Primary outcomes
1
Description
Delirium
Timepoint
At 14, 19 and 6 in the morning after the first intervention session and at 14, 19 and 6 in the morning after the second intervention.
Method of measurement
( Delirium Observation Scale (DOS
2
Description
Sleep Disorder
Timepoint
At 14:00 in the Mid day after the first intervention session and at 14:00 in the Mid day after the second intervention session.
Method of measurement
Richards Campbell Sleep Questionnaire
3
Description
Pain
Timepoint
In the Intervention group before the intervention and immediately after the intervention and the third time, two hours after the intervention, which will be completed 6 times in two days according to the two intervention sessions and in the control group, two times in the First day and Secound day After Extubation .
Method of measurement
Visual Analoge Scale
Secondary outcomes
1
Description
Blood Pressure
Timepoint
After surgery, immediately after entering to ICU OH, before each intervention session and after intervention and two hours after intervention and in the control group, in addition to entering the ward, once ,first day after The operation was evaluated and second time was in the second morning after surgery.
Method of measurement
Patients Blood Pressure Monitoring
2
Description
Heart Rate
Timepoint
After surgery, immediately after entering to ICU OH, before each intervention session and after intervention and two hours after intervention and in the control group, in addition to entering the ward, once ,first day after The operation was evaluated and second time was in the second morning after surgery.
Method of measurement
Patient Monitoring Device
3
Description
Respiratory Rate
Timepoint
Immediately after the patient's admission to the ICU OH department
Method of measurement
Patient Monitoring Device
4
Description
Saturation of Oxygen in Blood
Timepoint
Immediately after the patient's admission to the ICU OH department
Method of measurement
Patient Monitoring Device
5
Description
Patients temperature
Timepoint
Immediately after the patient's admission to the ICU OH department
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: Patients in the intervention group were enrolled after open heart surgery after entering ICU OH ward for primary vital signs and demographic characteristics. After the initial symptoms persisted and arterial blood gas tests resolved, the patient's endotracheal tube was removed according to the patient's ُsighns and physician's order. About 10 minutes after the endotracheal tube was removed, the first session of reflexology massage was performed for 20 minutes. The second intervention was performed in the morning after surgery.
Category
Treatment - Other
2
Description
Control group: The control group was enrolled after open heart surgery after entering ICU OH department for primary vital signs and demographic characteristics. In these patients, normal and routine care for patients was performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jamaran Heart Hospital
Full name of responsible person
Dr Mohammad Hassan Naseri
Street address
Jamaran Heart Hospital, Jamaran St, Niavaran St, Tehran