Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe

Sponsor
Cukurova University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05075694
Collaborator
(none)
48
1
2
9.3
5.2

Study Details

Study Description

Brief Summary

This study will be conducted as a single-blind randomized placebo-controlled experimental study to determine the effect of therapeutic touch sleep quality and fatigue in women in the menopausal period. The research is planned to be carried out between 15 November 2021 and 15 March 2022 in the Bornova gynecology oncology polyclinic of the İzmir Health Sciences University Tepecik Training and Research Hospital affiliated to the Ministry of Health. The population of the research consists of women application in the Gynecology Oncology Polyclinic of the İzmir Health Sciences University Tepecik Training and Research Hospital affiliated to the Ministry of Health. The number of samples was calculated in G*power 3.1.9.6 program. Accordingly, 21 women were calculated for each group, with effect size (d=1.37), 5% margin of error (α=0.05), and 99 % power (1-β=0.99). However, considering the possible losses, the number of samples was increased by 15 % and the study was planned to be conducted with 48 women, 24 in the intervention group and 24 in the placebo group. Data will be collected through the Personal Information Form, the Piper Fatigue Scale (PFS) and the Pittsburg Sleep Quality Index (PSQI). Data analysis will be performed using the IBM SPSS Statistics 24.0 program. Statistical significance will be taken 0.05. Therapeutic touch is thought to be one of the applications that can be used in improving women's health, as it is a non-drug application that is easy to apply, has no side effects and can be applied independently by midwives/nurses.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapeutic Touch
  • Other: Mimic touch
N/A

Detailed Description

The data collection phase of the study is planned to start in November 2021.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Investigation of the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women
Actual Study Start Date :
Dec 6, 2021
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experiment

Therapeutic touch is a treatment that takes an average of 15-20 min, in which energy in the universe is transferred through the hands of the practitioner to eliminate the imbalance in the individual's energy field and facilitate healing.

Behavioral: Therapeutic Touch
Therapeutic Touch

Placebo Comparator: Placebo

Placebo: Mimic Touch The placebo group will receive mimic touch instead of therapeutic touch. In this procedure, the therapeutic touch will be imitated, but the real procedure of the therapeutic touch will not be perform to the experimental group.

Other: Mimic touch
Mimic Touch

Outcome Measures

Primary Outcome Measures

  1. Sleep Quality [9 months]

    We will use Pittsburg Sleep Quality Index. The Pittsburg Sleep Quality Index was developed in 1989 by Buysse et al. (1989). Reliability and validity studies were conducted by Agargun and colleagues in Turkey, and Cronbach's alpha was 0.80. The scale comprised 18 items and 7 component scores. Every component was evaluated from 0 to 3. The total of these component points yielded the total score of the scale,which ranged from 0 to 21. A high score (5 or above) indicated poor sleep quality. Sleep quality was classified as good (0-4) and poor (5-21).

  2. Fatigue [9 months]

    We will use Piper Fatigue Severity Scale. This scale that was developed by Piper et al. (1998) consisted of 27items, and it evaluated fatigue of the patient with four subdimensions. Answers for every item were evaluated from 0 -10. The total fatigue score was calculated by adding points of 27 items and dividing the total score to the item number. A high score indicated a high perceived fatigue level. Reliability and validity studies for Turkish society was conducted by Can, and Cronbach's alpha was determined as 0.94

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Residing in the city center,

  2. Least literate,

  3. Between the ages of 40-60,

  4. Those who are in natural premenopause (irregular menstrual cycle in the last three months), perimenopause (amenorrhea for 3-11 months or increasing irregular menstruation) or postmenopause (amenorrhea for more than 12 months),

  5. Having sleep and fatigue problems,

  6. Open to communication and cooperation,

  7. Able to understand and speak Turkish,

  8. Not taking hormone replacement therapy,

  9. Not using drugs for sleep problems and depression,

  10. Without a diagnosis of medical psychiatric disease,

  11. Volunteered to participate in the research

Exclusion Criteria:
  1. Sensitivity or problem with touch,

  2. Medical procedure for any reason during the intervention

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ozlem Yalcinkaya Adana Saricam Turkey 01330

Sponsors and Collaborators

  • Cukurova University

Investigators

  • Study Chair: Ebru GOZUYESIL, PhD, Cukurova University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozlem Yalcinkaya, Msc Student, Cukurova University
ClinicalTrials.gov Identifier:
NCT05075694
Other Study ID Numbers:
  • 09.07.2021/46
First Posted:
Oct 13, 2021
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
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 Ozlem Yalcinkaya, Msc Student, Cukurova University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022