NCT06980558

Brief Summary

Patients undergoing urological surgery are usually elderly individuals and may experience sleep problems due to factors such as fear of death, anesthesia, and uncertainty. Insomnia can also cause problems such as delayed wound healing, increased pain, tension, and difficulty complying with treatment. This study aimed to improve sleep quality by performing gradual muscle exercises on patients undergoing urological surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 28, 2026

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 4, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

urological Surgerysleep quality

Outcome Measures

Primary Outcomes (1)

  • Richard's Campbell sleep scale

    It was developed by Richards in 1987 and examines the previous night's sleep in 6 parameters: sleep depth, falling asleep, frequency of waking, duration of wakefulness, quality of sleep, noise level, and is scored between 100 'very appropriate' and '0' 'not appropriate'. The higher the score received from the scale, the higher the patient's sleep quality is considered.

    on the morning of surgery, and on the 1st and 2nd day after surgery.

Secondary Outcomes (1)

  • Visual Analog Scale for Fatigue (VAS-F)

    on the morning of surgery, and on the 1st and 2nd day after surgery.

Study Arms (2)

Exercise group

EXPERIMENTAL

The individual will be given a position where communication can be easily established and where he/she feels comfortable. The content of the progressive relaxation exercise (PGE) will be explained to the patient. The 30-minute PGE application will be provided with verbal warnings.

Other: Progressive relaxation exercises

Control group

NO INTERVENTION

Patients will receive routine nursing care in the ward.

Interventions

Sit or lie down comfortably and close your eyes. * Feel the rhythm of your breathing. * Breathe in through your nose and out through your mouth throughout the process. * Relax as much as you can. * Get rid of negative thoughts in your mind. * Stretch your hands by hanging your arms down to your sides, tighten your fists as much as you can and then open them and let them relax.

Exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 18 years or older
  • No visual or auditory impairments
  • No use of relaxation techniques such as meditation, hypnosis, or yoga within
  • The past six months; absence of any diagnosed neurological or psychiatric disorders
  • No diagnosis or ongoing medical treatment for sleep apnea or other sleep disorders.

You may not qualify if:

  • Severe psychiatric condition,
  • Experienced any complications before or after surgery, were admitted to the
  • İntensive care unit,
  • Used sleep medications during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • naile akıncı, Dr.

    Fenerbahçe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 20, 2025

Study Start

May 4, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

April 28, 2026

Record last verified: 2025-05

Locations