Plain English Summary
Background and study aims
Wound pain interferes with the movement of post-operative patients, especially when they try to rise from the bed. Exhalation may release the tension of the abdominal wall and may reduce the motion pain due to rising.
Who can participate?
Post-operative patients of open renal biopsy or inguinal hernia repair surgery within 3 days after surgery.
What does the study involve?
The intervention involves patients breathing out while rising from bed.
What are the possible benefits and risks of participating?
Relieving motion-induced pain of post-operative wound may facilitate the physical activity of patients and may accelerate functional recovery.
Where is the study run from?
Sendai Social Insurance Hospital.
When is the study starting and how long is it expected to run for?
August 2011 until January 2012.
Who is funding the study?
Tohoku University School of Medicine.
Who is the main contact?
Hisao Sakagami
Trial website
Contact information
Type
Scientific
Primary contact
Mr Hisao Sakagami
ORCID ID
Contact details
Nagamachi 4-3-55
Taihaku-ku
Sendai
982-0011
Japan
+81-22-308-2071
h_sakagami@seiyogakuin.ac.jp
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1
Study information
Scientific title
Rising from the bed with exhalation to relieve motion-induced pain of post-operative wound after abdominal surgery: a non-randomised study
Acronym
Study hypothesis
Rising from the bed with exhalation may relieve motion-induced pain of post-operative wound after abdominal surgery
Ethics approval
Approved 01/11/2011, The Ethical Review Committee of Sendai Social Insurance Hospital (Currently JCHO Hospital) (Tsutumi-machi 3-16-1, Aoba-ku, Sendai, Japan; soumu@sendai.jcho.go.jp), ref: 2011-13.
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Pain after open renal biopsy or inguinal hernia repair surgery
Intervention
The intervention involves telling patients to breath out while rising from bed. Self-rated pain (measured using the visual analogue scale) is reported after rising and is compared to the pain while rising without exhalation. There is no follow up.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Subjective pain assessed by visual analog scale immediately after rising up with or without exhalation
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/08/2011
Overall trial end date
31/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who have undergone open renal biopsy or inguinal hernia repair surgery within the past 3 days.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
77
Total final enrolment
77
Participant exclusion criteria
1. Post-operative patients without wound pain
2. Incapable of rising up from their bed due to motor deficit.
Recruitment start date
01/11/2011
Recruitment end date
28/01/2012
Locations
Countries of recruitment
Japan
Trial participating centre
Sendai Social Insurance Hospital
Tsutumi-machi 3-16-1, Aoba-ku
Sendai
981-8501
Japan
Sponsor information
Organisation
Tohoku University School of Medicine
Sponsor details
Seiryo-cho 2-1
Aobaku
Sendai
980-8575
Japan
+81-22-717-8586
info@art.med.tohoku.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Tohoku University School of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in BMC Nursing.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/10/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list