What is the most effective instructional sequence, lecture followed by role play versus role play followed by lecture for developing nurses’ health communication competence in managing aggressive patients empathetically during a single teaching and learning session in a selected tertiary care hospital in Sri Lanka?

Study Setting
This single-site trial will be conducted at the Faculty of Nursing, University of Colombo in collaboration with Sri Jayewardenepura General Hospital (SJGH). Participants will be recruited from SJGH, while all teaching sessions and assessments will be conducted at the Faculty of Nursing.

Randomisation
Sample size was determined using G*Power software. Randomization will be used to allocate 40 eligible participants equally (1:1) to either the intervention group (role play followed by lecture) or the comparator group (lecture followed by role play) – twenty participants per each group, ensuring equal probability of assignment and minimising selection bias. An independent statistician, not involved in recruitment, intervention delivery, or outcome assessment, will generate the random allocation sequence using a computerized random number generator in Microsoft Excel. The allocation sequence will be securely stored and concealed from the research team to preserve methodological rigour and prevent bias.

Allocation concealment
Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared in advance according to the randomization list generated by an independent statistician. Each envelope will be opened only after written informed consent and completion of baseline (pre-test) assessments, by an independent research assistant not involved in other study procedures. The Principal Investigator will have no prior access to the allocation list and will be informed of group assignment only after enrolment. All steps related to envelope preparation, handling, and opening will be fully documented to maintain transparency and prevent allocation bias.

Blinding
Outcome assessors for MCQs and OSCEs will be blinded to group allocation. Due to the educational nature of the intervention, the Principal Investigator, facilitator, and participants will not be blinded.

Role Play - Lecture Sequence (Intervention Arm)

Participants in the intervention arm will receive an expert-validated, four-and-a-half-hour structured teaching session comprising the following components:

1. Introduction (10 minutes).
2. Instructional videos (15 minutes), consisting of two custom-selected videos developed by DBSAlliance (July 7, 2015) and Chris Hart (September 16, 2015).
3. Role-play demonstration (15 minutes), during which trained assistants will demonstrate a purpose-developed simulated nurse–patient interaction focusing on the empathetic management of aggressive behaviour.
4. Paired role-play practice (30 minutes), in which participants will practise de-escalation and therapeutic communication skills using a second scenario.
5. Feedback session (20 minutes), incorporating guided peer and facilitator feedback.
6. Lecture (60 minutes) developed based on nurses’ learning needs identified in earlier phases of the study and supported by relevant literature.

The session will be facilitated by a qualified nurse educator with more than five years of experience in teaching communication skills and a master’s degree in nursing. The same facilitator will deliver all components to ensure standardisation across the intervention.

Lecture–Role Play Sequence (Comparator Arm)

Participants in the comparator arm will receive an expert-validated, four-and-a-half-hour structured teaching session identical in content and duration to the intervention arm, differing only in the instructional sequence. The session will be conducted on the same day as the intervention arm following a 30-minute break.

1. Introduction (10 minutes).
2. Lecture (60 minutes) developed based on nurses’ learning needs identified in earlier phases of the study and supported by relevant literature.
3. Instructional videos (15 minutes), consisting of two custom-selected videos developed by DBSAlliance (July 7, 2015) and Chris Hart (September 16, 2015).
4. Role-play demonstration (15 minutes), during which the facilitator will demonstrate a purpose-developed simulated nurse–patient interaction using trained assistants, focusing on the empathetic management of aggressive behaviour.
5. Paired role-play practice (30 minutes), in which participants will practise de-escalation and therapeutic communication skills using a second scenario.
6. Feedback session (20 minutes), incorporating structured peer and facilitator feedback consistent with the intervention arm.

The same qualified nurse educator with more than five years of experience in teaching communication skills and a master’s degree in nursing will facilitate all components to ensure standardisation.

Outcome assessment will be conducted using pre-test and post-test MCQs and OSCEs at baseline (pre-intervention), immediately post-intervention, and at one-month follow-up to assess both immediate and retained improvements in health communication competence.

• Registered nurse currently working in a clinical setting at SJGH.
• Minimum of one year of continuous employment at SJGH.
• Actively engaged in patient care activities during the study period.
• Nurses of any age (no age restrictions)
• Both male and female nurses
• Willing to participate in the full intervention programme (4 and half hours) and follow-up assessments.

• Currently on extended leave (e.g., maternity leave, long-term medical leave).
• Nurses primarily engaged in administrative or non-clinical roles (e.g., nurse educators, ward managers with no direct patient contact).
• Prior participation in similar health communication training within the last 6 months.
• Inability to commit to both pre-test and post-test assessments due to shift constraints.
• Nurses who participated in earlier phases of this research study (i.e., Phase I or II of the exploratory study) (to avoid response bias and prior exposure effects that may influence the outcomes.)