Effects of Horticultural Therapy Combined with Intradermal Needle Therapy on Generalised Anxiety, Cortical Excitability and HPA-related Hormones in an Isolated Population during the COVID-19 Pandemic: Protocol for a Randomised Controlled Clinical Trial

Abstract

Abstract Introduction: Coronavirus disease 2019 (COVID-19) is a novel, highly infectious disease that is a severe danger to human life and has spawned a worldwide public health emergency. Most countries have implemented measures of isolation to prevent the spread of COVID-19, but related studies have shown that isolation increases the risk of anxiety, thereby affecting an individual’s physical and mental health. Simple and effective therapies for anxiety among quarantined populations need to be further explored. Horticultural activities can divert people's attention and alleviate negative emotions. Acupuncture is a conventional alternative therapy that has demonstrated efficacy in mood stabilization. The current study aimed to explore the clinical efficacy of combined Chinese and Western medicine therapies in alleviating anxiety among quarantined individuals during a pandemic. Methods In this prospective, randomised controlled trial (RCT), 150 patients with generalised anxiety disorder will be recruited from the Seventh Clinical College affiliated to Guangzhou University of Chinese Medicine. Eligible subjects will be randomly divided into the horticultural group (n = 50), intradermal acupuncture group (n = 50) and combined treatment group (n = 50). The horticulture group will engage in horticultural activity after basic treatment; the intradermal needle group will undergo intradermal needling after basic treatment; and the combined group will engage in horticultural activity and undergo intradermal needling after basic treatment. The treatments will be provided once a week for 8 weeks. The main outcome will be scores on the Hamilton Anxiety Scale (HAMA); secondary outcomes will include scores on the Self-Assessment Scale for Anxiety (SAS) and Pittsburgh Sleep Quality Index Scale (PSQI), serum indexes, and cortical excitability. All scales will be evaluated at baseline, at 2, 4, 6, and 8 weeks of treatment, and at follow-up; serological indicators and cortical excitability will be assessed at baseline and during week eight of treatment. Discussion The result of the experiment will help to clarify the therapeutic effects of horticultural therapy combined with intradermal needling on anxiety among isolated individuals and to elucidate the therapeutic mechanisms of this combined treatment among patients with anxiety. The purpose of this research is to eventually incorporate this combination approach into a treatment programme for anxiety, thereby significantly reducing the burden of mood disorders in the general population during public health emergencies. Trial registration: ClinicalTrials.gov ChiCTR2200066321. Registered on December 1, 2022