AnxietySlowPACENCT06192225
Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients
A study testing pre-trained guided slow paced breathing (~6 breaths per minute) in people with Anxiety, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The purpose of this single-center trial is to examine the effects of a slow-breathing technique 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),13 compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- pre-trained guided slow paced breathing (~6 breaths per minute)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Nov 2023to 2 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis
Who cannot join
- 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
Show all 9Show fewer
- Not able to understand Dutch
- No internet access
- Visual or hearing impairments interfering with reading and listening to the online material
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek hospital
Amsterdam, 1066 CX
Sabrine Hemmes, MD, PhD, +205124068, s.hemmes@nki.nl
About this study
Official title: Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients
The purpose of this single-center trial is to examine the effects of a slow-breathing technique 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),13 compared to usual care.
Read the detailed description
Rationale: 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, and postoperative pain.
The investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, PONV and patient satisfaction.
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 Study population: patients scheduled for surgery for breast cancer in the Antoni van Leeuwenhoek Hospital.
Intervention: Performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery.
Main study parameters: Anxiety scored by Spielberger's State Anxiety Inventory (STAI-S) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to the intervention. 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. All participants are asked to complete three questionnaires at baseline, and two short questionnaires on the day of surgery and at day 1.
- Conditions
- Anxiety
- Being tested
- pre-trained guided slow paced breathing (~6 breaths per minute)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-trained guided slow paced breathing (~6 breaths per minute)Behavioural
Slow PACE breathing
| Study group | Role | What they receive |
|---|---|---|
| Slow PACE arm | Experimental | The intervention consists of performance of pre-trained guided Slow PACE breathing by the patient at induction of anesthesia for breast cancer surgery. Receives: Behavioral: pre-trained guided slow paced breathing (~6 breaths per minute) |
| Control arm | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri operative anxiety
The present study aims to examine the effects of pre-trained guided Slow PACE 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.
The total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety symptoms. A cut-off score of 40 is commonly used to define probable clinical levels of anxiety.
Measured: 2 weeks
Secondary outcomes (8)
mean blood pressure before induction
MAP (mmHg)
Measured: 10 minutes
need of hypnotics during induction
total dose of hypnotics (propofol in milligrams)
Measured: 10 minutes
post-operative pain
visual analoge score (VAS) for pain, 0-10 points. A VAS score > 4 indicates the need of more pain medication
Measured: post-operative on recovery (1-2hours)
post-operative need of opioids
Mean cumulative intravenous opioid dose administered during admission in the recovery room - converted to morphine equivalent dose (MEQ)
Measured: post-operative on recovery (1-2hours)
postoperative nausea and vomiting (PONV)
Y/N
Measured: post-operative on recovery (1-2hours)
patient satisfaction
scale of 0 (extremely unsatisfied) to 10 (extremely satisfied)
Measured: 5 minutes on postoperative day 1
Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline
4-point scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety symptoms. A cut-off score of 40 is commonly used to define probable clinical levels of anxiety. The STAI-T will give an estimation of patients at high risk for anxiety.
Measured: once at baseline, duration 10 minutes
Hospital Anxiety and Depression Scale (HADS-A)
A questionnaire for detecting states of anxiety and depression in a hospital setting. The HADS-A is the anxiety subscale that consists of seven items. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0 to 21. A subscale score above 8 denotes anxiety.
Measured: once at baseline, duration 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start29 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, two-group, prospective, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192225
- Sponsor's protocol ID
- N23SLO
- Acronym
- SlowPACE
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: currently there are no other researchers
Publications
Spielberger, C.D. (2010). State-Trait Anxiety Inventory. In The Corsini Encyclopedia of Psychology (eds I.B. Weiner and W.E. Craighead).
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients
- ClinicalTrials.gov ID
- NCT06192225
- Acronym / sponsor ID
- SlowPACE / N23SLO
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this single-center trial is to examine the effects of a slow-breathing technique 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),13 compared to usual care.
Detailed description
Rationale: 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, and postoperative pain.
The investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, PONV and patient satisfaction.
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 Study population: patients scheduled for surgery for breast cancer in the Antoni van Leeuwenhoek Hospital.
Intervention: Performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery.
Main study parameters: Anxiety scored by Spielberger's State Anxiety Inventory (STAI-S) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to the intervention. 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. All participants are asked to complete three questionnaires at baseline, and two short questionnaires on the day of surgery and at day 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, two-group, prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Slow PACE arm | Experimental | Behavioral: pre-trained guided slow paced breathing (~6 breaths per minute)The intervention consists of performance of pre-trained guided Slow PACE breathing by the patient at induction of anesthesia for breast cancer surgery. |
| Control arm | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-trained guided slow paced breathing (~6 breaths per minute)Slow PACE breathing | Behavioural | Slow PACE arm |
Primary outcome
Peri operative anxiety
Time frame: 2 weeks
The present study aims to examine the effects of pre-trained guided Slow PACE 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. The total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety symptoms. A cut-off score of 40 is commonly used to define probable clinical levels of anxiety.
8 secondary outcomes
mean blood pressure before induction
Time frame: 10 minutes
need of hypnotics during induction
Time frame: 10 minutes
post-operative pain
Time frame: post-operative on recovery (1-2hours)
post-operative need of opioids
Time frame: post-operative on recovery (1-2hours)
postoperative nausea and vomiting (PONV)
Time frame: post-operative on recovery (1-2hours)
patient satisfaction
Time frame: 5 minutes on postoperative day 1
Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline
Time frame: once at baseline, duration 10 minutes
Hospital Anxiety and Depression Scale (HADS-A)
Time frame: once at baseline, duration 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- BackgroundSpielberger, C.D. (2010). State-Trait Anxiety Inventory. In The Corsini Encyclopedia of Psychology (eds I.B. Weiner and W.E. Craighead).
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Individual participant dataSharing planned: No. currently there are no other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-trained guided slow paced breathing (~6 breaths per minute) in people with Anxiety, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabrine NT Hemmes, PhD (+20205124068, s.hemmes@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri operative anxiety (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.