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Complementary therapy for the management of 'white coat hypertension syndrome' (a condition where a patient's blood pressure is higher when measured at a doctor's office than in other settings)

A randomised control trial, evaluating the effect of a personalised complementary therapy intervention for the management of white coat hypertension syndrome within early phase oncology clinical trial patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91249076
Enrollment
200
Registered
2024-11-26
Start date
2023-10-14
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White coat hypertension Mental and Behavioural Disorders

Interventions

Patients will be randomised into two study arms using electronic Recap 1:1 randomisation. The interventions last 1 hour with no follow-up activities. Arm 1 Patients randomised to arm 1
the complementary therapy arm, will be assessed by a trained complementary therapist, to create a personalised complementary therapy treatment programme. Participants will either receive massage, incl
arm 1 participants would be reviewed by the medical and nursing team and a decision would be made to transfer the participant to a standard of care. Arm 2 Arm 2 participants will receive a standard
discussion with patients around how they are feeling (BP repeated after discussion). At the next visit, if BP is still high, the patient is to be referred to the medical team. This would include a det
to examine possible causes of elevated BP, such as undiagnosed hypertension or drug-related. If no obvious cause is found, consider home BP monitoring (at least twice daily for 7 days). At the next ap

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Men or women 16 years and above 2. Confirmed diagnosis of advanced cancer 3. Confirmed GAD-7 score of 10 or above and / or 1WCH (1 WCHA criteria: A discrepancy of more than 20/10 mmHg between clinic and median daytime BP (NICE, 2022))

Exclusion criteria

Exclusion criteria: 1. Previous confirmed diagnosis of hypertension 2. Unconfirmed WCH 3. Patients receiving a treatment with known cardio toxicity that effects BP

Design outcomes

Primary

MeasureTime frame
1. Blood pressure measured using a sphygmomanometer at pre and post-complementary therapy, and pre and post-standard-of-care visits 2. Anxiety measured using the Generalized Anxiety Disorder (GAD-7) scale at every visit, before any intervention of standard of care treatment for WCH or GAD

Secondary

MeasureTime frame
The rate of white coat hypertension syndrome measured using data collected in patient medical records at visit one and visit two, as part of screening

Countries

England, United Kingdom

Contacts

Public ContactBen Hood
ben.hood@nhs.net+44 (0)1912139217

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026