This study aims to examine the effects of guided slow paced breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, State scale (STAI-S…
ID
Source
Brief title
Condition
- Other condition
- Respiratory disorders NEC
Synonym
Health condition
Stressreductie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Spielberger's State-Trait Anxiety Inventory, State scale (STAI-S).
Secondary outcome
- mean blood pressure before induction
- need of hypnotics during induction
- post-operative pain and need of opioids
- postoperative nausea and vomiting (PONV)
- patient satisfaction
- compare anxiety trait scored by Spielberger's State Anxiety Inventory
(STAI-T)13 and general anxiety scored by the anxiety subscale of the Hospital
Anxiety and Depression Scale (HADS-A) at baseline
Background summary
In the perioperative period anxiety for anesthesia and the surgical procedure
is common. Breast cancer surgery patients have a higher level of anxiety
compared to other patients undergoing (cancer) surgery. Relaxation techniques,
like breath focus with deep belly breathing are easy to learn and can have a
beneficial effect on postoperative anxiety, pain, and postoperative nausea and
vomiting (PONV), but the quality of evidence is low. Slow paced breathing at a
frequency of 6 breaths per minute can possibly increase vagal activation,
decrease anxiety, reduce mean blood pressure, postoperative pain and PONV. The
beneficial effects of slow paced breathing in the perioperative period have not
been examined to date.
Study objective
This study aims to examine the effects of guided slow paced breathing performed
at induction of anesthesia in patients undergoing surgery for breast cancer on
anxiety, scored by Spielberger's State-Trait Anxiety Inventory, State scale
(STAI-S), compared to usual care.
Study design
Single center, two-group, prospective, randomized controlled trial
Intervention
Study groups
Slow PACE group
Participants randomized in the Slow PACE group will receive a link to the study
site with a comprehensive instruction video explaining the Slow PACE breathing
technique. Furthermore a *kick-off* video-call is planned with an investigator
to give additional instructions and to answer any questions regarding the
breathing technique. Slow PACE breathing is a simple technique of deep belly
breathing in a low frequency (6 breaths per minute), performed in supine
position. After the initial instructions participants are asked to practice
Slow PACE breathing daily for at least 5 minutes, guided by an audio-guide.
Participants will receive a daily email with a reminder and a link in which
they can score if they had time to practice the slow-paced breathing the day
before.
On the day of surgery, the participant will be asked to start with the Slow
PACE breathing technique just before start of induction of anesthesia in the
operation room, guided by the investigator and the same audio-fragment as used
for training.
Anesthesia and all intra-operative care will be given to all patients as usual.
Control group
Participants in the control group do not have to prepare or train
preoperatively. They will recieve all care as usual.
Study burden and risks
There are no risks related to the intervention.
All participants are asked to complete three questionnaires at baseline, and
two short questionnaires on the day of surgery and at day 1.
Participants randomized in the intervention group are trained in slow paced
breathing after inclusion and asked to practice the technique daily until the
day of surgery and to keep score of this daily by email.
We aim to provide everything for the study digitally, so the patient does not
have to visit the hospital extra.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Female
- Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis
Exclusion criteria
- Age < 18 years - ASA >= 4 - History of severe pulmonary illness: severe asthma
or severe chronic obstructive pulmonary disease (COPD) GOLD III or IV - Known
or suspected severe psychiatric disorder - Unable to give written or oral
informed consent - Patient refusal - Not able to understand Dutch - No internet
access - Visual or hearing impairments interfering with reading and listening
to the online material
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 | NL84554.041.23 |