Development and evaluation of an oral ketamine nursing care protocol (KNP) for patients undergoing ketamine therapy in the psychiatric care setting of a selected tertiary care hospital: a mixed-methods study

Introduction

Depressionis a leading cause of disability worldwide, and among its various forms, MajorDepressive Disorder (MDD) poses serious challenges to both patients and mentalhealth providers. A significant proportion of individuals with MDD do notrespond to at least two standard antidepressants, and these patients are atincreased risk of suicide and often experience chronic emotional suffering andpoor social functioning. In recent years, ketamine has emerged as a novel andpromising treatment option for MDD. Originally used as an aesthetic, ketaminein low doses shows rapid antidepressant and anti-suicidal effects. Althoughintravenous ketamine is commonly used in hospitals, its administration requirestrained anaesthetists and monitoring, making it less feasible in routineoutpatient settings. Oral ketamine, by contrast, is more practical,cost-effective, and patient-friendly, particularly in low-resource settingslike India. However, oral ketamine therapy can have side effects such asincreased blood pressure, dissociative symptoms, and potential for misuse ifnot properly monitored. This underscores the critical role of nurses in safelyadministering the treatment, monitoring for adverse effects, and providingpsychological support to patients. Despite this need, there is currently nostandardized nursing care protocol for oral ketamine therapy in psychiatricsettings. Rationale for the study

Therationale for this study lies in improving clinical outcomes and safety inketamine therapy through structured nursing guidelines. Nurses are thefrontline caregivers in psychiatric hospitals, and their knowledge, attitude,and practice greatly influence treatment success. By creating and implementinga structured protocol, this research intends to support nurses with clear stepsfor monitoring side effects, managing complications, and improving patientinteraction during ketamine treatment. This protocol will also reduce carevariability and enhance patient outcomes. The objectives of the study are todevelop an oral ketamine nursing care protocol (KNP) for patients undergoingketamine therapy in psychiatric settings and to evaluate its usability inimproving nursing officers’ knowledge, attitude, and practice.

Noveltyand feasibility

Thisstudy is innovative as it is the first to develop a formalized protocolspecifically for oral ketamine administration in psychiatric settings. Itintroduces a structured, evidence-informed approach to a treatment that isincreasingly being adopted worldwide. The feasibility of the study is supportedby the availability of nurses at AIIMS Bibinagar and the possibility ofconducting a pilot trial before the full implementation.

Methodology

Theresearch question guiding this project is: What is the effect of an oralketamine nursing care protocol (KNP) on improving nurses’ knowledge, attitude,practice, and acceptance toward ketamine therapy in psychiatric care? The studyhypothesizes that nurses trained using the protocol will show significantlyimproved knowledge, attitude, and practices compared to their pre-traininglevels.

Thisresearch will be conducted in two phases using a mixed-methods design. In PhaseI, a protocol will be developed through expert consultation using the Delphimethod. It will be field tested with trained and untrained nurse groups toassess effectiveness. In Phase II, qualitative feedback will be gatheredthrough focus group discussions (FGDs) to explore nurse experiences with theprotocol. This feedback will help refine the protocol for broader use. Themethodology includes a quasi-experimental design with purposive sampling of 140nurses, divided equally into intervention and control groups. Data will becollected through structured questionnaires and FGDs, and analyzed usingstatistical and thematic analysis techniques. The inclusion criteria target regularnursing officers with at least one year of experience, while those unwilling toparticipate or previously exposed to ketamine therapy will be excluded.

Oralketamine therapy refers to the administration of ketamine in an oralformulation, primarily intended to alleviate severe depressive symptoms,including suicidal ideation, in individuals diagnosed with treatment-resistantdepression. In the present study, patients receiving oral ketamine therapy willbegin with an initial dose of 50 mg or 75 mg, followed by incremental increasesof 25 mg in subsequent sessions, reaching a maximum dose of 150 mg asprescribed by a psychiatrist. The treatment regimen will comprise a total ofsix sessions. The oral ketamine nursing care protocol (KNP) is defined as astructured and standardized guideline created to assist nursing officers in thesafe administration and monitoring of oral ketamine therapy. The protocol willbe developed and evaluated in two phases. Phase 1 involves the formulation of adraft protocol based on a comprehensive literature review and focus groupdiscussions with nurses, patients, and psychiatrists. The final draft will bevalidated using the Delphi method involving expert consensus. Phase 2 willfocus on administering the protocol to nurses selected via purposive surveysfor evaluating its effectiveness.

Knowledgewill be measured as the nursing officers’ understanding of oral ketaminetherapy, 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 readinesstoward oral ketamine therapy, evaluated through a validated attitude assessmenttool. The practice will be assessed as the nurses’ self-reported behaviors andresponsibilities in administering and monitoring oral ketamine therapy inclinical settings, using a structured practice questionnaire. Acceptance isdefined as the level of willingness, confidence, and commitment shown bynursing officers in adopting and implementing the KNP, measured through self-reportedevaluations that explore perceived benefits, concerns, confidence levels, andadherence to safety standards in patient care.

Theexpected outcome of this study is a validated and practical nursing careprotocol that will improve the safety and effectiveness of oral ketaminetherapy in psychiatric care. The study aims to enhance nurse competence andpatient care standards, thereby contributing to better mental health outcomesin treatment-resistant depression.