Condition category
Not Applicable
Date applied
12/02/2019
Date assigned
01/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review. 28/02/2019: Trial's existence confirmed by the ethical committee of JCHO Hospital.