Clinical trial · Interventional
Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients
Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients
NCT06192225CI-TRIAL-00072745SlowPACEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pre-trained guided slow paced breathing (~6 breaths per minute) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Slow PACE arm
- description
- The intervention consists of performance of pre-trained guided Slow PACE breathing by the patient at induction of anesthesia for breast cancer surgery.
- interventionNames
- Behavioral: pre-trained guided slow paced breathing (~6 breaths per minute)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Care as usual
Primary outcomes (1)
- measure
- Peri operative anxiety
- timeFrame
- 2 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSpielberger, C.D. (2010). State-Trait Anxiety Inventory. In The Corsini Encyclopedia of Psychology (eds I.B. Weiner and W.E. Craighead).
- BACKGROUNDZigmond 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. PMID 6880820