The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06079385
Collaborator
(none)
70
1
2
3.1
22.9

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the effectiveness and reliability of acupuncture treatment in patients experiencing impaired sleep quality after a stroke. Additionally, the goal is to reduce the need for multiple medications and/or high-dose drug usage in the treatment of these complications in patients

Condition or Disease Intervention/Treatment Phase
  • Other: Acupuncture treatment
N/A

Detailed Description

The aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in patients experiencing insomnia in the early post-stroke period. In this prospective, randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient rehabilitation were included. Participants were randomly divided into two groups: the acupuncture group receiving acupuncture therapy and standard rehabilitation program. The control group receiving only the standard rehabilitation program. The acupuncture group received acupuncture treatment twice a week for 4 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores were assessed three times at baseline, at the 4th week, and at the 8th week. The results of the study indicated that the acupuncture group demonstrated a significant improvement in sleep quality compared to the control group. Significant differences were observed between the baseline PSQI scores and the

PSQI scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p:

0.008). The change between baseline and 8th-week PSQI scores was also significant (p: 0.000 and p: 0.000). However, in the acupuncture group, the decrease in PSQI scores was significantly greater compared to the control group. The addition of acupuncture therapy to standard treatment resulted in a significant improvement in sleep quality. Additionally, the baseline PSQI scores were found to be correlated with the severity of depression.This study suggests that acupuncture therapy can be an effective intervention for improving sleep quality in patients with early post-stroke insomnia.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Oct 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupuncture group

The patients who received acupuncture treatment in addition to a standard rehabilitation program

Other: Acupuncture treatment
Acupuncture treatment with needles

No Intervention: Control group

The patients who received the standard rehabilitation program.

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index [0 day, 4th week and 8th week]

    The index helps to evaluate sleep quality of patient. The scores range from 0 to 21 and the authors suggest that a score >5 be considered as a significant sleep disturbance.

Secondary Outcome Measures

  1. Hamilton Depression Rating Scale [0 day, 4th week and 8th week]

    The scale is used to evaluate symptoms related to depression. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale

  2. Hamilton Anxiety Rating Scale [0 day, 4th week and 8th week]

    The scale is used to evaluate symptoms related to anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  3. Barthel Index [0 day]

    it helps to evaluate the patient's functional status. scores of 0-20 indicate "total" dependency scores of 21-60 indicate "severe" dependency scores of 61-90 indicate "moderate" dependency scores of 91-99 indicate "slight" dependency

  4. Mini-Mental State Examination [0 day]

    the test is used to evaluate patient's cognitive status. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • being between 18-80 years of age,

  • having a minimum of 2 and a maximum of 6 months elapsed since the ischemic stroke, -volunteering to participate in the study,

  • having a mini-mental test score above 17.

Exclusion Criteria:
  • history of insomnia or depression before stroke,

  • psychiatric medication use,

  • psychiatric illness, aphasia, sleep apnea syndrome,

  • decompensated cardiac, renal, or hepatic insufficiency, pregnancy,

  • presence of infection in the areas where acupuncture would be applied.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Nur Kesiktas, MD, Prof, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06079385
Other Study ID Numbers:
  • IstPRMTRH3
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2023