Clinical trial comparing the effects of patient communication before general anesthesia on post-operation pain and agitation of patients after endoscopic sinus surgery in the recovery room
This study evaluates the effect of patient communication before general anesthesia on post-operation pain and agitation. After getting approved by ethics committee of Mashhad University of Medical Sciences, 64 patients who were scheduled for sinus endoscopic surgery were allocated according to the block randomization to case and control groups. It was double blind for the patients and the researchers. The patients did not know about their groups and both groups were in the separated rooms in ward. Intervention groups were not informed in presence of the controls. Also another blind researcher from group assignment evaluated pain and agitation in recovery room. The patients, who were all over 18 years old and they were all non-smokers with no drug addiction or long-term (>6 months) use of analgesic and/or NSAIDs entered the study consecutively. The Patients who faced complications during anesthesia were excluded from the study.
This study performed at Ghaem hospital, a Mashhad University of Medical Sciences affiliated hospital, from January to December 2011. The case group were involved in a 15-20 minutes of informative and supportive communication once in the night before the surgery and once again for 5-10 minutes just before the surgery. The control group did not receive that communication. The same technique for general anesthesia was performed for both groups. After surgery, all of the patients were under the care of one nurse who was kept blind to the patients' group in the recovery. Pain severity was estimated using visual analog scale and non-verbal analog scale. Agitation was scaled using Riker’s Sedation-Agitation Scale.
main outcome measures (variables): pain, agitation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404278589N3
Registration date:2014-11-04, 1393/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-04, 1393/08/13
Registrant information
Name
Fatemeh Hajimohamadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 2392
Email address
hajimoha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-05-23, 1390/03/02
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of patient communication before general anesthesia on post-operation pain and agitation of patients after endoscopic sinus surgery in the recovery room
Public title
The effect of communicating with patient before anesthesia on pain and agitation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : patients, who were all over 18 years old and they were all non-smokers with no drug addiction or long-term (>6 months) use of analgesic and/or NSAIDs, Patients were diagnosed and scheduled for limited sinus endoscopy surgery (opening maxillary, ethmoid and sphenoid sinus with or without partial resection of middle cornea without septoplasty including polyposis and sinusitis) entered the study consecutively.
Exclusion criteria: Patients who faced complications during anesthesia (cardiac arrest, bradycardia (HR<40) and bronchospasm), needed a more advanced sinus endoscopic surgery, in whom cautery was used for hemostasis or surgery, duration of longer than 4 hours were excluded from the study.
Age
From 18 years old to 61 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vakilabad St., Mashhad
City
Mashhad
Postal code
Approval date
2011-07-09, 1390/04/18
Ethics committee reference number
891029
Health conditions studied
1
Description of health condition studied
acute pain and agitation
ICD-10 code
R52.9, R45
ICD-10 code description
Generalized pain NOS, Worries NOS
Primary outcomes
1
Description
pain
Timepoint
Entering the recovery, During the recovery entrance, Leaving the recovery
Method of measurement
Visual Analog Scale, Non-verbal Analog Scale
2
Description
Agitation
Timepoint
Entering the recovery, During the recovery entrance, Leaving the recovery
Method of measurement
Riker Sedation-Agitation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: The patients of case group were involved in a 15-20 minutes of informative and supportive communication once in the night before the surgery and once again for 5-10 minutes just before the surgery. All of the informative and supportive plans were designed by psychologists and anesthesiologist. Supportive communication plan include; the researcher introduces his/her self and asks the patients about their name, job, education, experience of their previous surgery. The researcher encourages the patients to express their feeling and anxiety about their surgery. Also assures the patients about their complete coverage during surgery. And says that there is not any facial incision in your face in this surgery. We have not had any mortality in this kind of surgery in this hospital. Informative communication plan; the Patients are informed about general anesthesia and its equipment such as mask, anesthesia machine, ambo bag, monitoring, common side-effects that may occur during anesthesia, post-op pain, nausea, vomiting and how to control them. Also they are informed about how improve their breathing with closed nasal way and when they can eat and drink after surgery. They are informed about intra nasal pack (two days after surgery is removed) and some others routine actions (washing their nose with normal saline).
Category
Prevention
2
Description
Intervention2: The patients of control group did not receive any informative and supportive communication and were only treated with routine OR procedures. If they had some questions, the stuffs answered to patient’s questions.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital, Mashhad
Full name of responsible person
Fatemeh Navidi, Master of Sciences in Nursing
Street address
Ghaem hospital, Daneshgah st, Mashhad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Mashhad University of Medical Sciences
Full name of responsible person
Jalil Tavakoli Afshari
Street address
Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Grant name
1324/511
Grant code / Reference number
891029
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Mashhad University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Navidi
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Amiralam hospital, Saadi St., Tehran
City
Tehran
Postal code
1637818561
Phone
+98 21 6670 6107
Fax
+98 66704805
Email
saharnavidi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amiralam hospital, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Navidi
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Amiralam hospital, Saadi St., Tehran
City
Tehran
Postal code
1637818561
Phone
+98 21 6670 6107
Fax
+98 66704805
Email
saharnavidi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Amiralam hospita, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Navidi
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Amiralam hospital, saadi St., Tehran
City
Tehran
Postal code
1637818561
Phone
+98 21 6670 6107
Fax
+98 66704805
Email
saharnavidi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)