The objective of this study is to get insight in the effect of the Cardio Thoracic Harness for men and the Cardio thoracic bra for women. The harness and the bra possibly have an important role in pain management. The producer of the harness and the…
ID
Source
Brief title
Condition
- Thoracic disorders (excl lung and pleura)
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is pain. Pain can be seen as the central factor.
From the literature can be concluded that when a patient experiences a lot of
pain a patient will be possibly mobilised not so fast and less frequent. Pain
can also lead to fear related to pain. If a patient experience a lot of pain to
the chest by activity he or she will possibly develope some fear for pain to
activity. Pain can lead to a diminished lung function. When a patient
experience a lot of pain to the chest by breathing deeply, he or she will
breath less deeply. This results in a diminished lung function. The pain
intensity will be measured with the National Rating Scale.
Secondary outcome
The secundary study parameters are:
- lung function: With the help of spirometry the patients lung volume and lung
capacity can be measured. The lung function will be measured during three days
ones a day.
- Mobility and independence: With the use of the Barthel Index score the extent
of (in) dependence can be measured. The Barthel Index will be scored during
three days ones a day.
- Fear related to pain: The Tampa Scale for Kinesiophobia will be used to
measure fear related to pain. The score on this questioning can give
information about the extent of possible fear related to pain during the days
after the surgery. The questioning contains 17 questions.
Background summary
There is less reliable research to the effect of a new product, the Cardio
Thoracic Harness. Earlier research has been done to a variant of the Cardio
Thoracic Harness, The Sternum Support Harness. In this publicated research the
writer concludes that the sternum Support harness may have a positive effect on
pain management after open heart surgery but more research is needed to verify
this. Also a larger patient population is necessary.
Another factor of relevance can be found in the literature. There is a growing
interest in improving postoperative pain management. This increased interest
can be concluded from the growing availability of effective methods for pain
management and a growing awareness of effects of postoperative pain relief.
The central problem statement of this research is if the Cardio Thoracic
Harness reduces pain after a sternotomy.
Study objective
The objective of this study is to get insight in the effect of the Cardio
Thoracic Harness for men and the Cardio thoracic bra for women. The harness and
the bra possibly have an important role in pain management. The producer of the
harness and the bra describes that the harness and the bra can help stimulating
the patient to cough effective and to breath deeply. The producer describes
that the harness and the bra could lead to more comfort for the patient and
more support of the chest. Together these aspects could lead to a fast
recovery. Fast recovery leads to a fast discharge from the hospital. Fast
discharge leads to a cost reduction.
Study design
It is an intervention study in which two groups will be compared. One group is
the intervention group where the men get a harness and the women get a bra to
wear. The control group receives the regular care, the use of a pillow. Between
these two groups the same aspects will be measured. This makes it possible to
compare the results of both groups. The aspects that will be measured are: pain
intensity, lung function, mobility and independence and fear of pain.
Intervention
The intervention for men is the Cardio Thoracic Harness. For women they
developed the cardio thoracic Bra. These products have to be worn 24 hours a
day. This is necessary because also during the night support is needed by
coughing, breathing deeply and mobilisation. The control group receives a
pillow.
Study burden and risks
The extent of the burden for the patients expressed in time is about 2 hours
and 15 minutes. This time contains information about the research, instructions
and the measurements. Except the lung function the data will be collected oral.
The researcher will come to the patient twice a day to do the measurements.
The risks associated with participation to the research:
It could be possible that the Harness or the Bra not always offers comfort to
the patients. This is because the products have to be worn continiously.
P. Debeyeplein 1
6200 MD Maastricht
Nederland
P. Debeyeplein 1
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- The need for open heart surgery
- The patient is between 65 and 79 years old
Exclusion criteria
- Insufficient knowledge about the Dutch language
- Cognitive deficit
Design
Recruitment
Medical products/devices used
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 | NL12175.068.06 |