Introduction

Depression is a leading cause of disability worldwide, and among its various forms, Major Depressive Disorder (MDD) poses serious challenges to both patients and mental health providers. A significant proportion of individuals with MDD do not respond to at least two standard antidepressants, and these patients are at increased risk of suicide and often experience chronic emotional suffering and poor social functioning. In recent years, ketamine has emerged as a novel and promising treatment option for MDD. Originally used as an aesthetic, ketamine in low doses shows rapid antidepressant and anti-suicidal effects. Although intravenous ketamine is commonly used in hospitals, its administration requires trained anaesthetists and monitoring, making it less feasible in routine outpatient settings. Oral ketamine, by contrast, is more practical, cost-effective, and patient-friendly, particularly in low-resource settings like India. However, oral ketamine therapy can have side effects such as increased blood pressure, dissociative symptoms, and potential for misuse if not properly monitored. This underscores the critical role of nurses in safely administering the treatment, monitoring for adverse effects, and providing psychological support to patients. Despite this need, there is currently no standardized nursing care protocol for oral ketamine therapy in psychiatric settings. Rationale for the study

The rationale for this study lies in improving clinical outcomes and safety in ketamine therapy through structured nursing guidelines. Nurses are the frontline caregivers in psychiatric hospitals, and their knowledge, attitude, and practice greatly influence treatment success. By creating and implementing a structured protocol, this research intends to support nurses with clear steps for monitoring side effects, managing complications, and improving patient interaction during ketamine treatment. This protocol will also reduce care variability and enhance patient outcomes. The objectives of the study are to develop an oral ketamine nursing care protocol (KNP) for patients undergoing ketamine therapy in psychiatric settings and to evaluate its usability in improving nursing officers’ knowledge, attitude, and practice.

Novelty and feasibility

This study is innovative as it is the first to develop a formalized protocol specifically for oral ketamine administration in psychiatric settings. It introduces a structured, evidence-informed approach to a treatment that is increasingly being adopted worldwide. The feasibility of the study is supported by the availability of nurses at AIIMS Bibinagar and the possibility of conducting a pilot trial before the full implementation.

Methodology

The research question guiding this project is: What is the effect of an oral ketamine nursing care protocol (KNP) on improving nurses’ knowledge, attitude, practice, and acceptance toward ketamine therapy in psychiatric care? The study hypothesizes that nurses trained using the protocol will show significantly improved knowledge, attitude, and practices compared to their pre-training levels.

This research will be conducted in two phases using a mixed-methods design. In Phase I, a protocol will be developed through expert consultation using the Delphi method. It will be field tested with trained and untrained nurse groups to assess effectiveness. In Phase II, qualitative feedback will be gathered through focus group discussions (FGDs) to explore nurse experiences with the protocol. This feedback will help refine the protocol for broader use. The methodology includes a quasi-experimental design with purposive sampling of 140 nurses, divided equally into intervention and control groups. Data will be collected through structured questionnaires and FGDs, and analyzed using statistical and thematic analysis techniques. The inclusion criteria target regular nursing officers with at least one year of experience, while those unwilling to participate or previously exposed to ketamine therapy will be excluded.

Oral ketamine therapy refers to the administration of ketamine in an oral formulation, primarily intended to alleviate severe depressive symptoms, including suicidal ideation, in individuals diagnosed with treatment-resistant depression. In the present study, patients receiving oral ketamine therapy will begin with an initial dose of 50 mg or 75 mg, followed by incremental increases of 25 mg in subsequent sessions, reaching a maximum dose of 150 mg as prescribed by a psychiatrist. The treatment regimen will comprise a total of six sessions. The oral ketamine nursing care protocol (KNP) is defined as a structured and standardized guideline created to assist nursing officers in the safe administration and monitoring of oral ketamine therapy. The protocol will be developed and evaluated in two phases. Phase 1 involves the formulation of a draft protocol based on a comprehensive literature review and focus group discussions with nurses, patients, and psychiatrists. The final draft will be validated using the Delphi method involving expert consensus. Phase 2 will focus on administering the protocol to nurses selected via purposive surveys for evaluating its effectiveness.

Knowledge will be measured as the nursing officers’ understanding of oral ketamine therapy, covering its indications, contraindications, potential side effects, and treatment duration, using a self-reported structured questionnaire. Attitude refers to the nurses’ overall perceptions, beliefs, and readiness toward oral ketamine therapy, evaluated through a validated attitude assessment tool. The practice will be assessed as the nurses’ self-reported behaviors and responsibilities in administering and monitoring oral ketamine therapy in clinical settings, using a structured practice questionnaire. Acceptance is defined as the level of willingness, confidence, and commitment shown by nursing officers in adopting and implementing the KNP, measured through self-reported evaluations that explore perceived benefits, concerns, confidence levels, and adherence to safety standards in patient care.

The expected outcome of this study is a validated and practical nursing care protocol that will improve the safety and effectiveness of oral ketamine therapy in psychiatric care. The study aims to enhance nurse competence and patient care standards, thereby contributing to better mental health outcomes in treatment-resistant depression.