Use of convenient aerobic exercise and heating compress to improvement of gas pain and upper abdominal pain after surgery
| ISRCTN | ISRCTN85867468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85867468 |
- Submission date
- 30/07/2021
- Registration date
- 30/07/2021
- Last edited
- 12/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
After laparoscopic (keyhole) surgery, the pain is less than the traditional open surgery, and the recovery is faster. However, during laparoscopic surgery, carbon dioxide gas must be used to penetrate the body in order to make the surgical field clearer. As a result, 35% to 80% of patients experience gas pain and discomfort after surgery, causing trouble. If non-medicinal, simple, and easy-to-operate nursing measures can be used to reduce the occurrence of gas pain and discomfort, it will reduce the use of medical costs.
Who can participate?
Women aged 20 years and above who are admitted to the hospital for gynecological laparoscopic surgery
What does the study involve?
Participants are randomly allocated to the experimental or the control group.
Four hours after the operation, the anesthetic had withdrawn, the experimental group began to perform aerobic exercises for 5-10 times of deep breathing, upper extremity expansion exercises, and hot compresses for 30 minutes. The intervention was performed at 4, 6, 12, and 24 hours after the operation.
The control group followed the routine care of the ward.
What are the possible benefits and risks of participating?
Benefits: The intervention may reduce pain after the operation.
Risks: A hot compress is used to improve blood circulation in the shoulder and neck. If burns occur during use, the host of this study will bear all the medical expenses. If you feel uncomfortable during the process, you can ask the host for explanation or assistance at any time.
Where is the study run from?
Chung Shan Medical University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
December 2020 to April 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Ju-Ying Hsu, cathys661212@gmail.com
Contact information
Scientific
Chung Shan Medical University
No. 1, Aly. 1, Ln. 17, Sec. 1
Xiangshang Rd.
West Dist.
Taichung
403008
Taiwan
 ORCID ID |
0000-0002-9356-5590 |
|---|---|
| Phone | +886 975662261 |
| cathys661212@gmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluation of the effect of aerobic exercise and hot compress on the improvement of gas pain and upper abdominal pain after laparoscopic surgery |
| Study objectives | 1. Through the interventional measures of aerobic exercise and heating compress, the experimental group has significantly improved gas pain and upper abdominal pain than the control group 2. Through the interventional measures of aerobic exercise and heating compress, the experimental group has improved the quality of postoperative recovery than the control group |
| Ethics approval(s) | Approved 24/12/2020, Institutional Review Board Chung Shan Medical University Hospital (No.110, Sec.1, Chien-Kuo N. Road, Taichung, Taiwan 402; +886 (0)4-24739595; irb@csh.org.tw), ref: CS1-20189 |
| Health condition(s) or problem(s) studied | Upper abdominal pain after laparoscopic surgery |
| Intervention | Participants are randomly assigned to the experimental group and control group, four hours after the operation. Randomisation uses a random number table. The experimental group starts to perform aerobic exercises for 5-10 deep breaths, chest expansion exercises and hot compresses for 30 minutes each time. The intervention time is as follows: Four times at 4, 6, 12, and 24 hours after operation. The control group followed the routine care of the ward. |
| Intervention type | Behavioural |
| Primary outcome measure | Pain is measured used a visual analogue scale at 4 hours and 24 hours after operation |
| Secondary outcome measures | Recovery from surgery is measured QoR-40 questionnaire at 4 hours and 24 hours after operation |
| Overall study start date | 24/12/2020 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Those gynecological patients who have undergone laparoscopic surgery 2. Adults over 20 years old 3. A clear consciousness can speak, read and understand Mandarin. And those who can fully cooperate 4. Those who accept this experiment and sign the consent form. 5. Those who take general anesthesia 6. If the experimental group and the control group are in the same ward, at least one ward will be separated 7. The attending physician agrees |
| Key exclusion criteria | 1. Failed laparoscopic surgery was changed to laparotomy 2. Those who have had a shoulder injury 3. BMI value> 30mg/m² 4. Mental patients who are unable to cooperate in the implementation of intervention measures 5. The experimental group and the control group are allocated by random assignment. If the experimental group and the control group are allocated to the same ward, the second income patient will be excluded. Avoid cross-effects and violate research ethics |
| Date of first enrolment | 28/01/2021 |
| Date of final enrolment | 29/04/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Chien-Kuo N. Road
Taichung
402
Taiwan
Sponsor information
Hospital/treatment centre
No. 1, Aly. 1, Ln. 17, Sec. 1
Xiangshang Rd.
West Dist.
Taichung
403
Taiwan
| Phone | +886 24739595 |
|---|---|
| cs1731@csmu.edu.tw | |
| Website | http://www.csh.org.tw/ |
"ROR" |
https://ror.org/059ryjv25 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 12/10/2021 | No | No |
Additional files
Editorial Notes
12/10/2021: The following changes were made to the trial record:
1. The participant level data was changed from 'to be made available at a later date' to 'stored in repository'
2. A dataset was uploaded as an additional file.
02/08/2021: Internal review.
30/07/2021: Trial's existence confirmed by Institutional Review Board Chung Shan Medical University Hospital.
