Effect of melatonin and Valerian Supplementation on Postoperative Sleep Quality in Patients Undergoing Primary Hemiarthroplasty : A Randomized Double-Blind Clinical Trial Protocol

Effect of Melatonin and Valerian Supplementation on Postoperative Sleep Quality in Patients Undergoing Primary Hemiarthroplasty: A Randomized Double-Blind Clinical Trial Protocol

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180404039188N6

Enrollment

160

Registered

2026-04-29

Start date

2026-06-20

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disorder.

Interventions

Intervention 1: Intervention group: 1. Group 1 (Melatonin): 3 mg Melatonin tablet + 1 placebo capsule. Intervention 2: Intervention group: 2. Group 2 (Valerian): 400 mg Valerian capsule + 1 placebo ta

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: a BMI between 18.5 and 35 kg/m undergoing primary hemiarthroplasty who report postoperative sleep disruption (PSQI=)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: days 0, 14, 2months, 3 months. Method of measurement: pittsburgh sleep quality index.	—

Secondary

Measure	Time frame
CRP. Timepoint: DAYS 0, 14, month2. Method of measurement: Elisa kit.;IL-6. Timepoint: days 0, 14 and month2. Method of measurement: Elisa kit.;Morning level of cortisol. Timepoint: days 0,14, month2. Method of measurement: elisa kit.;Pain score. Timepoint: days 0, 14, month2, month3. Method of measurement: vas score.;SLEEPNESS SCALE. Timepoint: days 0, 14 and month 2 and month 3. Method of measurement: Epworth Sleepniess scale.;Anxiety scale. Timepoint: days 0, 14, month2, month3. Method of measurement: Hamilton Anxiety Rating Scale.;Depression scale. Timepoint: days 0, 14, month2, month3. Method of measurement: Depression Inventory- short form.;Insomnia severity. Timepoint: days 0, 14, month2, month3. Method of measurement: Insomnia Severity scale.;Quality of life. Timepoint: days 0, 14, month2, month3. Method of measurement: WHO Quality of Life-BREF (WHOQOL-BREF).	—

Measure

Time frame

CRP. Timepoint: DAYS 0, 14, month2. Method of measurement: Elisa kit.;IL-6. Timepoint: days 0, 14 and month2. Method of measurement: Elisa kit.;Morning level of cortisol. Timepoint: days 0,14, month2. Method of measurement: elisa kit.;Pain score. Timepoint: days 0, 14, month2, month3. Method of measurement: vas score.;SLEEPNESS SCALE. Timepoint: days 0, 14 and month 2 and month 3. Method of measurement: Epworth Sleepniess scale.;Anxiety scale. Timepoint: days 0, 14, month2, month3. Method of measurement: Hamilton Anxiety Rating Scale.;Depression scale. Timepoint: days 0, 14, month2, month3. Method of measurement: Depression Inventory- short form.;Insomnia severity. Timepoint: days 0, 14, month2, month3. Method of measurement: Insomnia Severity scale.;Quality of life. Timepoint: days 0, 14, month2, month3. Method of measurement: WHO Quality of Life-BREF (WHOQOL-BREF).

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactreza zandi

Shahid Beheshti University of Medical Sciences

reza.zandi@sbmu.ac.ir22432564

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026