MenopauseNCT05075694
Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe
A study testing Therapeutic Touch in people with Menopause and Sleep, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak Turkish.
Who cannot join
- The women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women
This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.
Read the detailed description
Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.
Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).
Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.
- Conditions
- Menopause, Sleep, Fatigue, Therapeutic Touch
- Being tested
- Therapeutic Touch, Sham Therapeutic Touch
- Keywords
- Menopause, Sleep, Fatigue, Therapeutic touch
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Therapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure.
Sham Therapeutic TouchOther
The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with STTPP. The practice was implemented by not centering or intending to help to heal, by moving at a longer distance, and by imitating the TT practice protocol visually.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Therapeutic touch (TT) 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. The intervention group (TT group) received therapeutic touch for 10 minutes a day for five consecutive days. The practice was implemented in line with Therapeutic Practice Procedure. Receives: Behavioral: Therapeutic Touch |
| Control | Sham comparator | Placebo: Sham Therapeutic Touch (STT) The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with Sham Therapeutic Touch Practice Procedure (STTPP). Receives: Other: Sham Therapeutic Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
The Turkish version of the Pittsburgh Sleep Quality Index (PSQI), which was developed by Buyssee et al. (1989), was used for the assessment of sleep quality. It is a self-report scale that makes a quantitative assessment of sleep quality and sleep disorders over a one-month time interval [30]. Turkish reliability and validity of the scale were performed by Ağargün et al. in our country (1996) [31]. The scale is composed of 18 items and seven sub-scales, which include Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorders, Use of Sleeping Drugs, and Daytime Dysfunction. Each item is scored between 0 and 3. The total score of the seven sub-scales gives the PSQI score. Scores to be obtained from the scale range between 0 and 21. A total score greater than 5 indicates "poor sleep quality." Cronbach's alpha reliability coefficient of the PSQI was reported 0,804 in the Turkish adaptation of the scale [31].
Measured: 9 months
Fatigue
The Turkish version of the Piper Fatigue Scale (PFS) was utilized to assess fatigue. PFS was developed by Barbara F. Piper et al. in 1987 [32]. Turkish reliability and validity of the scale were performed by Can et al. (2001) [33]. The scale responded on a 5-point Likert scale has 22 items and four sub-scales and it aims to assess individuals' subjective perceptions about fatigue. The sub-scales are Behavioral/Severity, Affective Meaning, Sensory, and Cognitive /Mood. Calculation of the sub-scale scores is done by summing all the items in that sub-scale and dividing it by the number of items. Higher scores indicate higher fatigue levels. Total Cronbach's alpha value was reported to be 0,99 in the Turkish reliability and validity of the scale [33].
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start15 Dec 2021
- Primary completion15 Jan 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Yalcinkaya, Cukurova University
- Investigators
- Ebru GOZUYESIL, PhD, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075694
- Sponsor's protocol ID
- 09.07.2021/46
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yalcinkaya O, Gozuyesil E. The effect of therapeutic touch on sleep quality and fatigue in menopausal women. Explore (NY). 2024 Mar-Apr;20(2):222-230. doi: 10.1016/j.explore.2023.08.007. Epub 2023 Aug 23.
PubMed 37640590
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women
- ClinicalTrials.gov ID
- NCT05075694
- Acronym / sponsor ID
- 09.07.2021/46
- Conditions
- Menopause, Sleep, Fatigue, Therapeutic Touch
- Keywords
- Menopause, Sleep, Fatigue, Therapeutic touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.
Detailed description
Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.
Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).
Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Behavioral: Therapeutic TouchTherapeutic touch (TT) 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. The intervention group (TT group) received therapeutic touch for 10 minutes a day for five consecutive days. The practice was implemented in line with Therapeutic Practice Procedure. |
| Control | Sham comparator | Other: Sham Therapeutic TouchPlacebo: Sham Therapeutic Touch (STT) The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with Sham Therapeutic Touch Practice Procedure (STTPP). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak Turkish.
Key exclusion criteria (1 listed)
- The women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchTherapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure. | Behavioural | Experiment |
| Sham Therapeutic TouchThe control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with STTPP. The practice was implemented by not centering or intending to help to heal, by moving at a longer distance, and by imitating the TT practice protocol visually. | Other | Control |
Primary outcome
Sleep Quality
Time frame: 9 months
The Turkish version of the Pittsburgh Sleep Quality Index (PSQI), which was developed by Buyssee et al. (1989), was used for the assessment of sleep quality. It is a self-report scale that makes a quantitative assessment of sleep quality and sleep disorders over a one-month time interval [30]. Turkish reliability and validity of the scale were performed by Ağargün et al. in our country (1996) [31]. The scale is composed of 18 items and seven sub-scales, which include Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorders, Use of Sleeping Drugs, and Daytime Dysfunction. Each item is scored between 0 and 3. The total score of the seven sub-scales gives the PSQI score. Scores to be obtained from the scale range between 0 and 21. A total score greater than 5 indicates "poor sleep quality." Cronbach's alpha reliability coefficient of the PSQI was reported 0,804 in the Turkish adaptation of the scale [31].
Fatigue
Time frame: 9 months
The Turkish version of the Piper Fatigue Scale (PFS) was utilized to assess fatigue. PFS was developed by Barbara F. Piper et al. in 1987 [32]. Turkish reliability and validity of the scale were performed by Can et al. (2001) [33]. The scale responded on a 5-point Likert scale has 22 items and four sub-scales and it aims to assess individuals' subjective perceptions about fatigue. The sub-scales are Behavioral/Severity, Affective Meaning, Sensory, and Cognitive /Mood. Calculation of the sub-scale scores is done by summing all the items in that sub-scale and dividing it by the number of items. Higher scores indicate higher fatigue levels. Total Cronbach's alpha value was reported to be 0,99 in the Turkish reliability and validity of the scale [33].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 37640590Yalcinkaya O, Gozuyesil E. The effect of therapeutic touch on sleep quality and fatigue in menopausal women. Explore (NY). 2024 Mar-Apr;20(2):222-230. doi: 10.1016/j.explore.2023.08.007. Epub 2023 Aug 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru GOZUYESIL, PhD study chair
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Menopause and Sleep, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05075694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.