Can exhalation while rising from bed relieve motion-induced pain after abdominal surgery?
| ISRCTN | ISRCTN95502262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95502262 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1 |
| Sponsor | Tohoku University School of Medicine |
| Funder | Tohoku University School of Medicine |
- 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
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
Scientific
Nagamachi 4-3-55, Taihaku-ku
Sendai
982-0011
Japan
| Phone | +81-22-308-2071 |
|---|---|
| h_sakagami@seiyogakuin.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Rising from the bed with exhalation to relieve motion-induced pain of post-operative wound after abdominal surgery: a non-randomised study |
| Study objectives | Rising 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) studied | 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 |
| Primary outcome measure(s) |
Subjective pain assessed by visual analog scale immediately after rising up with or without exhalation |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 77 |
| Total final enrolment | 77 |
| Key inclusion criteria | Patients who have undergone open renal biopsy or inguinal hernia repair surgery within the past 3 days. |
| Key exclusion criteria | 1. Post-operative patients without wound pain 2. Incapable of rising up from their bed due to motor deficit. |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 28/01/2012 |
Locations
Countries of recruitment
- Japan
Study participating centre
Sendai
981-8501
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| 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.
