To investigate whether deep and slow breathing exercises can reduce pain induced by mobilizing from bed to chair after major abdominal surgery, compared to a reading task.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijn na buik chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the Visual Analogue Scale pain score (VAS) during
mobilization on the third postoperative day.
Secondary outcome
Other parameters are: VAS during mobilization on the fourth postoperative day
before intervention, VAS pain scores in rest before and after intervention,
quantitative sensory testing and conditioned pain modulation parameters,
cytokine and cortisol response and outcomes of pain-related psychological
questionnaires (PCS, PASS and STAI). Adverse events and feasibility (MTSQ).
Background summary
Adequate post-operative pain management leads to less morbidity and mortality,
early mobilization, shortened hospital stay, reduced costs and increased
patient satisfaction. Early mobilization plays an important role in this
enhanced recovery. However, reaching an adequate level of pain relief remains
challenging and currently used analgesics have many side effects. Deep and slow
breathing techniques (DSB) have shown hypoalgesic effects in other conditions,
and may possibly contribute to post-operative analgesia.
Study objective
To investigate whether deep and slow breathing exercises can reduce pain
induced by mobilizing from bed to chair after major abdominal surgery, compared
to a reading task.
Study design
A pilot study using a randomized controlled parallel design:
- Intervention: deep and slow breathing
- Control intervention: reading task
Study burden and risks
The subjects participating will obtain no direct personal benefit. The results
from the study will provide new insights into the possible usefulness of deep
and slow breathing after surgery. The risks for the participants are
negligible.
Geert Groteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Groteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1.Patient is at least 18 years old on the day the informed consent form will be signed.
2.Patient is undergoing elective major abdominal surgery.
3.The surgical procedure has an estimated duration of at least 90 minutes, excluding the time to induce anesthesia.
4.Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
5.Patient is willing and able to comply with the trial protocol.
6.Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent.
Exclusion criteria
1. Severe chronic obstructive or another pulmonary disease that impairs patient from practicing deep and slow breathing
2.Patient has (a history of) a (chronic) pain syndrome that interferes with the interpretation of QST results.
3.Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
4.Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
5.Female patient is pregnant during the course of the study.
6.Patient is allergic to white plasters.
7. Any condition that disables the patient to make an independent transfer from bed to chair, e.g. being wheelchair bound.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51607.091.14 |