Can exhalation while rising from bed relieve motion-induced pain after abdominal surgery?

ISRCTN ISRCTN95502262
DOI https://doi.org/10.1186/ISRCTN95502262
Secondary identifying numbers 1
Submission date
12/02/2019
Registration date
01/03/2019
Last edited
20/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Hisao Sakagami
Scientific

Nagamachi 4-3-55, Taihaku-ku
Sendai
982-0011
Japan

Phone +81-22-308-2071
Email h_sakagami@seiyogakuin.ac.jp

Study information

Study designInterventional non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleRising from the bed with exhalation to relieve motion-induced pain of post-operative wound after abdominal surgery: a non-randomised study
Study objectivesRising from the bed with exhalation may relieve motion-induced pain of post-operative wound after abdominal surgery
Ethics approval(s)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.
Health condition(s) or problem(s) studiedPain after open renal biopsy or inguinal hernia repair surgery
InterventionThe 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 typeBehavioural
Primary outcome measureSubjective pain assessed by visual analog scale immediately after rising up with or without exhalation
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/08/2011
Completion date31/01/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants77
Total final enrolment77
Key inclusion criteriaPatients who have undergone open renal biopsy or inguinal hernia repair surgery within the past 3 days.
Key exclusion criteria1. Post-operative patients without wound pain
2. Incapable of rising up from their bed due to motor deficit.
Date of first enrolment01/11/2011
Date of final enrolment28/01/2012

Locations

Countries of recruitment

  • Japan

Study participating centre

Sendai Social Insurance Hospital
Tsutumi-machi 3-16-1, Aoba-ku
Sendai
981-8501
Japan

Sponsor information

Tohoku University School of Medicine
University/education

Seiryo-cho 2-1, Aobaku
Sendai
980-8575
Japan

Phone +81-22-717-8586
Email info@art.med.tohoku.ac.uk
ROR logo "ROR" https://ror.org/01dq60k83

Funders

Funder type

University/education

Tohoku University School of Medicine

No information available

Results and Publications

Intention to publish date31/10/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in BMC Nursing.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Preprint results 26/05/2020 20/09/2021 No No

Editorial Notes

20/09/2021: Preprint reference added.
06/11/2019: Internal review.
08/03/2019: Internal review.
28/02/2019: Trial's existence confirmed by the ethical committee of JCHO Hospital.