Shirodhara for Nidranasha (Primary Insomnia): A Pre–Post PSQI Study at an NABH-Accredited Ayurveda Hospital

Shirodhara for Nidranasha (Primary Insomnia): A Pre–Post PSQI Study is a clinical research project that measures whether a standard course of Shirodhara — the continuous pouring of warmed medicated oil over the forehead — is associated with a measurable change in sleep quality, using the Pittsburgh Sleep Quality Index (PSQI) as the outcome instrument.

Nidra (sleep) is counted among the trayopastambhas, the three sub-pillars that support life alongside ahara (food) and brahmacharya (regulated conduct). Disturbed sleep, or Nidranasha, is among the most common complaints presenting at Ayurveda OPDs, often accompanying stress, long screen exposure and shift work. Shirodhara is a flagship Panchakarma procedure for it, yet departmental practice is rarely documented with an internationally recognised outcome scale — which is exactly the gap a BAMS student research project under the NCISM curriculum can close.

This study is carried out in the Panchakarma OPD of a fictional but realistically modelled NABH-accredited Ayurveda hospital, following the hospital's written Shirodhara SOP. Consecutive consenting adults with primary insomnia complaints receive their physician-prescribed Shirodhara course (typically 14 sittings of about 45 minutes each), and PSQI is scored at baseline, at the end of the course and at a two-week follow-up.

The bundle contains the full research toolkit: protocol, case-record form, anonymisation and ethics workflow, SPSS analysis plan, report skeleton, presentation and a viva bank. It is a pre–post observational study, not a randomised trial — a deliberately honest design a third- or fourth-year student can actually execute, defend and publish as a paper.

Insomnia is one of the most frequent complaints at Ayurveda hospital OPDs, and Shirodhara is one of the most frequently administered procedures for it. Yet the hospital's own evidence for the procedure usually stops at the treatment register: oil used, sittings given, patient discharged. No validated, patient-reported sleep measure is captured, so the department cannot quantify its own results, compare them with published literature, or answer an NABH quality-assurance review with data. Published Shirodhara studies exist but are few and mostly small, and none describes a routine teaching-hospital cohort with a standardised outcome instrument.

There is a need for a rigorous, ethically designed, student-executable pre–post study that scores a real Panchakarma OPD cohort with the Pittsburgh Sleep Quality Index before and after a documented Shirodhara course, analyses the change with appropriate paired statistics, and reports the findings honestly — including its limitations as an uncontrolled, unblinded observational design.

Abstract

This project evaluates sleep quality before and after a standardised Shirodhara course in adults presenting with Nidranasha (primary insomnia) at the Panchakarma OPD of a NABH-accredited Ayurveda hospital. It is a prospective, single-group, pre–post observational study with consecutive sampling, using the Pittsburgh Sleep Quality Index (PSQI) at baseline, end of treatment (day 14) and two-week follow-up. Paired statistics (paired t-test or Wilcoxon signed-rank after a Shapiro–Wilk check) quantify the change; the protocol, ethics pathway and analysis plan are documented end to end.

Introduction

Charaka treats Nidra as one of the trayopastambhas — when sleep is wholesome in timing, quality and duration, it supports bala (strength), complexion, digestive fire and clarity of mind. Nidranasha, its pathological absence, is described across the Brihat Trayi and routinely dominates the evening OPD of any busy Ayurveda hospital. Shirodhara — the steady stream of warmed medicated taila over the forehead from a fixed height, usually for 30–45 minutes — is the department's workhorse for it, commonly with Ksheerabala, Brahmi or Chandanadi taila chosen by the physician.

Existing system / literature gap

Clinical audits inside Ayurveda hospitals record the procedure beautifully — oil, temperature, duration, sittings — but almost never record a validated patient-reported outcome. Published evidence exists (for example, a 2014 case series in Global Advances in Health and Medicine reported improvement on the Insomnia Severity Index after five Shirodhara sessions, and recent narrative reviews summarise growing but still limited trials), yet few teaching hospitals can show their own before–after numbers on a standard scale. Consequently, the department cannot answer the simplest quality question an NABH assessor or a curious student may ask: does our own Shirodhara cohort's PSQI actually fall?

Proposed study

• Design: prospective, single-arm, pre–post observational study with two-week follow-up; reported in line with STROBE-informed observational-study practice.
• Setting and sample: Panchakarma OPD of a modelled 120-bed NABH-accredited Ayurveda hospital; consecutive sampling; target 60 evaluable adults (18–65 years) over one recruitment season.
• Intervention as practised: physician-prescribed Shirodhara per hospital SOP (oil chosen individually, warmed to a controlled lukewarm range, poured from a fixed height for about 45 minutes per sitting, 14 sittings).
• Outcomes: primary — PSQI global score (0–21) change from baseline to day 14; secondary — PSQI component scores, follow-up change, and a structured description of the oil prescriptions used.
• Analysis: descriptive statistics, Shapiro–Wilk normality check, paired t-test or Wilcoxon signed-rank, effect size, and exploratory subgroup views by taila and age band in SPSS; all analyses on a de-identified master sheet.

Feasibility

• Clinical: recruitment rides on an existing, high-volume OPD service; no new treatment is invented, so no new risk is introduced.
• Academic: the design needs one researcher, one validated questionnaire, a register, Excel and SPSS — all within an NCISM student research project's reach in about 20 weeks.
• Ethical: IEC approval, written informed consent, and anonymisation before analysis; the report carries aggregate data only, never identifiable patient records.

In scope

• One Panchakarma OPD of a modelled NABH-accredited Ayurveda hospital; one recruitment season of approximately 12 weeks.
• Adults aged 18–65 with primary insomnia complaints (PSQI global > 5 at baseline) who are prescribed Shirodhara as part of their individualised management.
• Outcome measurement with PSQI (baseline, day 14, two-week follow-up), a structured case-record form and register abstraction.
• Paired statistical analysis of before–after change in SPSS, with effect sizes and exploratory subgroups.

Out of scope

• Randomisation, a control arm, blinding or placebo oil — this is an observational pre–post study, not a trial.
• Polysomnography, actigraphy or other objective sleep laboratory measures.
• Secondary insomnia (due to pregnancy, major psychiatric illness, substance use or severe systemic disease), which is excluded at screening.
• Pharmacoeconomic analysis, and any attempt to compare oils head-to-head with adequate power.

Research design: prospective, single-group, pre–post (before–after) observational study with a two-week post-treatment follow-up, reported with STROBE-informed discipline. Consecutive sampling is used to limit selection bias: every eligible patient arriving at the Panchakarma OPD during the recruitment window is screened in order of arrival.

Participants: adults 18–65 with primary insomnia complaints and baseline PSQI global score > 5; excluded — secondary insomnia, pregnancy, severe psychiatric or systemic illness, shift-work schedules that cannot be stabilised during the study, and unwillingness to give written consent.

Intervention: physician-prescribed Shirodhara as per the hospital SOP — warmed medicated taila (Ksheerabala, Brahmi or Chandanadi, per physician judgement) poured in a continuous stream over the forehead from a fixed height for about 45 minutes per sitting, 14 sittings; co-prescribed internal medicines are recorded and reported, not restricted.

Statistical analysis plan: descriptives (mean ± SD or median [IQR]); Shapiro–Wilk test for normality of PSQI change; paired t-test (or Wilcoxon signed-rank) for global and component scores, α = 0.05; Cohen's d (or r) for effect size; no multiplicity adjustment, as secondary analyses are explicitly exploratory. Analyses are done on an intention-to-treat-like basis with last-observation sensitivity handling for dropouts, and the number of dropouts is reported.

The study runs as a one-directional clinical research pipeline: governance first, then screening, consent, measurement, intervention, de-identification, statistics and reporting. Three roles operate it — the student researcher (screening, PSQI administration, data entry), the treating physicians (prescription and SOP adherence) and the IEC (approval and oversight), with the department statistician consulted for the analysis plan.

flowchart TD
  A["IEC approval and hospital permission"] --> B["Screen consecutive Panchakarma OPD patients<br/>with Nidranasha complaints"]
  B --> C{"Eligible? 18–65 yrs, primary insomnia,<br/>PSQI > 5, written consent possible"}
  C -->|Yes| D["Written informed consent taken"]
  C -->|No| E["Excluded — reason logged in screening log"]
  D --> F["Baseline: PSQI + CRF<br/>(prakriti, manas prakriti, sleep history)"]
  F --> G["Shirodhara course per hospital SOP<br/>(taila per physician, ~45 min × 14 sittings)"]
  G --> H["Day-14 PSQI + procedure documentation"]
  H --> I["Two-week follow-up PSQI"]
  I --> J["De-identification: code number replaces<br/>name / MRN before analysis"]
  J --> K["Excel master sheet with double entry<br/>and range checks"]
  K --> L{"Shapiro–Wilk on PSQI change"}
  L -->|Normal| M["Paired t-test + Cohen's d"]
  L -->|Non-normal| N["Wilcoxon signed-rank + effect size r"]
  M --> O["IMRaD report + STROBE-informed write-up"]
  N --> O

Two design safeguards sit inside this pipeline. First, measurement and treatment are separated: the PSQI is administered by the researcher before the physician's prescription is finalised for the study record, so baseline scores cannot be nudged by treatment expectations. Second, de-identification happens before any statistics — the SPSS dataset never carries names, MRNs or addresses, matching both IEC conditions and NABH record-confidentiality practice.

• Register a follow-up randomised waitlist-controlled trial of Shirodhara versus Sham Dhara (neutral medium, matching temperature) on CTRI, powered on the PSQI change observed here.
• Add objective measurement — wrist actigraphy for one week at baseline and day 14 — to triangulate the self-reported PSQI.
• Compare two standard tailas (Ksheerabala vs Chandanadi) in an adequately powered head-to-head design.
• Extend follow-up to 12 weeks to see whether the sleep gains persist or fade.
• Build the audit into a permanent NABH-friendly quality indicator: monthly PSQI dashboards for the Panchakarma OPD.
• Test a tablet-based PSQI collection workflow to cut data-entry load and enable real-time departmental reports.