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StressNCT06583629

Effect of Emotion Freedom Technique on Perceived Stress, Resilience and Sexual Satisfaction Among Women After Mastectomy

A study testing Emotional Freedom Technique in people with Stress and Sexual Satisfaction, run by Helwan University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A quasi-experimental design was utilized, involving a convenient sample of 112 Egyptian mastectomized women. Data were collected and analyzed to determine the correlations between the variables of interest. Read more about this study

Who is it for?
Ages 20 to 49 years, women only
Conditions the study is for
Stress, Sexual Satisfaction, Mastectomy
What is being tested?
Emotional Freedom Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteEgypt
Study dates
15 Jan 2024to 21 Jul 2024
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 20 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • absence of any psychiatric diagnoses
  • no prior exposure to courses on emotional freedom techniques
  • no chronic illnesses

Who cannot join

  • previously psychiatric diagnosed women
  • women with previous experiences with emotional freedom techniques
  • Women with chronic illness

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Beni-Suef University Hospital

    Banī Suwayf, Beni Suweif Governorate, 2711860

Other trials in Egypt

About this study

A quasi-experimental design was utilized, involving a convenient sample of 112 Egyptian mastectomized women. Data were collected and analyzed to determine the correlations between the variables of interest.

Read the detailed description

Aim of the Study:

This study set out to evaluate the effect of emotion freedom technique on perceived stress, Resilience and sexual satisfaction among women after mastectomy.

Setting and study design:

The study was conducted in the surgical department, Beni-Suef University Hospital, at Beni-Suef Governorate, Egypt. A quasi-experimental design was utilized to carry out the study.

Participants:

A total of 112 Egyptian women who had undergone mastectomy were recruited based on the following inclusion criteria: a) absence of any psychiatric diagnoses, b) no prior exposure to courses on emotional freedom techniques, c) no chronic illnesses, and d) willingness to participate in the study.

Study instruments and measures:

For this study, a well-structured interview using a previously prepared questionnaire with the participants using the participants' mother tongue (Arabic) was employed. The researchers developed the questionnaire, incorporating relevant Connor-Davidson Resilience scale items, Perceived Stress Scale, and the Sexual Satisfaction Index from related studies. The instruments were translated from English to Arabic at the Center for Specialized Languages, Faculty of Arts, Helwan University. A panel of experts in psychology, psychiatry and psychiatric nursing then evaluated the instrument's validity and suitability for use with mastectomized women. The questionnaire's validity was further confirmed through a pilot study involving 10 participants. Then the questionnaire was distributed by the researchers through performing an interview with the participants in the surgical department, Beni-Suef University Hospital.

This research instrument encompasses four primary sections, the first one containing the participant's basic and educational information, including items such as: age, educational level, place of residence, marital status, occupation, economic status and medical history of the women. The second section was Connor-Davidson Resilience Scale (CD-RISC) which was developed Kathryn and Jonathan, (2003). Connor-Davidson Resilience Scale (CD-RISC) comprises 25 items that measure resilience or capacity to change and cope with adversity. Respondents indicated their response on a 5-point Likert scale with higher scores indicating greater resilience. Scoring criteria: As for the scoring system of the CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience. Cronbach's alpha coefficient for the full scale was 0.89.

The third research instrument's part was the Perceived Stress Scale (PSS-10) which was developed by Cohen and colleagues, (1983). The Perceived Stress Scale (PSS) is widely considered the gold standard instrument for measuring stress perception. This questionnaire is used to assess the degree to which a respondent finds circumstances in their life to be unpredictable, uncontrollable, and/or overwhelming. Questions on the PSS ask the respondent to rate their feelings and thoughts for the past month indicating that a relatively recent time frame is assessed. PSS designed to measure the degree to which situations in one's life are appraised as stressful. This version of the PPS had 10 items: four positive items (items 4, 5, 7, 8) and six negative items (items 1, 2, 3, 6, 9 and 10). Each item is scored on a 5-point scale, ranging from 0 (never) to 4 (very often). The positive elements' ratings are reversed, for example, 0=4, 1=3, 2=2, etc., and then summing across all 10 items, a higher score indicates more perceived stress. We evaluated the internal consistency of the questionnaire with Cronbach's alpha, resulting in a satisfactory value of 0.82.

The fourth part of the research instrument was the Sexual Satisfaction Index (SSI) which was developed by Leth-Nissen and colleagues, (2021). There were nine items in this edition of the SSI: five positive items (items 1, 2, 3, 8, and 9) and four negative ones (items 4, 5, 6, and 7). Every item is scored on a 5-point rating system, with the negative ratings being reversed and ranging from 1 (strongly disagree) to 5 (strongly agree). The SSI's total score falls between 1 and 45. A greater level of sexual satisfaction is indicated by a higher sum score. Estimates of internal reliability for the SSI produced acceptable Cronbach's alpha coefficients to the full scale 0.88.

Procedures:

The data collection for this study was instituted after obtaining the ethical approval from the faculty of medicine at Beni-Suef University, followed by the approval from the hospital authorities to conduct the current study after an explanation of the aim of the study.

The researchers prepared the research instruments after reviewing related articles and periodicals. The instrument was translated from English to the participant's mother tongue, "Arabic," at the Center for Specialized Languages of the Faculty of Arts, Helwan University. A panel of experts in psychology, psychiatry, and psychiatric/mental health nursing then evaluated the instrument's validity and suitability for use with nursing students.

The survey was successfully conducted with participants in the hospital in the form of a well-structured interview, where the researchers met the participants, explained the aim of the study to them, assessed their ability to participate, and obtained their written informed consent; the informed consent, explaining the study's aim, confidentiality guarantees, and the ability to withdraw from the study at any time without any fear. Then the data was collected. The emotional freedom technique was applied through various phases. The preparatory phase involved reviewing the studies and available literature related to the research problem and theoretical knowledge using evidence-based articles, textbooks, internet periodicals, and journals. The assessment phase, in which the researchers communicated with the accountable nursing supervisors in the surgical department daily to find out how many patients were recently admitted to the surgical department and if they fulfilled the inclusion criteria. The researchers clarified the nature and the aim of the study to all participants who were involved in the study after taking their written approval of participation. The researchers interviewed the participants (pre-the emotional freedom technique interventions) to complete the socio-demographic, perceived stress, resilience, and sexual satisfaction. The interview lasted between 25 and 35 minutes.

Planning Phase (Development of Emotional Freedom Technique Interventions): The objectives were formulated with careful consideration of the needs of the women involved, drawing on recent significant research and expert validation from the nursing field. These objectives were revised and refined based on expert feedback to ensure they could be applied in various ways. One such approach included the creation of a booklet, which highlighted the key aspects of the emotional freedom technique specifically for women who had undergone mastectomies. The booklet, designed by researchers, was written in simple Arabic and accompanied by illustrative photos. Implementation phase: The implementation of emotional freedom technique interventions was carried out by the researchers. Interventions were provided three times per week. The emotional freedom technique, with approximately (55 minutes) included theoretical information about breast cancer, signs and symptoms, treatment and its effect on stress, resilience, and sexual satisfaction (25 minutes), and steps of applying the emotional freedom technique (30 minutes). The evaluation phase aimed to reevaluate the participants to find any variations in their baseline response level following the intervention phase. Both before and after using the emotional freedom technique, the researchers assessed participants' perceived stress, resilience, and sexual satisfaction twice. The same tools were used by the researchers to compare them and investigate any notable differences in the results.

Being tested
Emotional Freedom Technique
Keywords
Emotional Freedom Technique, Stress, Resilience, Sexual satisfaction
Medical subject headings
Orgasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Freedom TechniqueBehavioural

    Also called Tapping

    EFT is a self-help technique that incorporates conscious awareness of thoughts and feelings with a gentle touch involving tapping with fingertips on acupuncture/acupressure points on the face, hands, and body. EFT also helps relieve primary physical and emotional symptoms. Gary Craig created EFT, which involved lightly tapping on the body on 12 acupressure sites (also known as acupoints). This acupoints are situated along the body's meridians, or virtual energy channels

Study groups in NCT06583629
Study groupRoleWhat they receive
Enrolled participantsExperimentalNot described
Receives: Behavioral: Emotional Freedom Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress

    Perceived Stress Scale (PSS-10) which was developed by Cohen and colleagues, (1983). Perceived Stress Scale (PSS) is widely considered the gold standard instrument for measuring stress perception. This questionnaire is used to assess the degree to which a respondent finds circumstances in their life to be unpredictable, uncontrollable, and/or overwhelming. Questions on the PSS ask the respondent to rate their feelings and thoughts for the past month indicating that a relatively recent time frame is assessed. PSS designed to measure the degree to which situations in one's life are appraised as stressful. This version of the PPS had 10 items: four positive items (items 4, 5, 7, 8) and six negative items (items 1, 2, 3, 6, 9 and 10). Each item is scored on a 5-point scale, ranging from 0 (never) to 4 (very often). The positive elements' ratings are reversed, for example, 0=4, 1=3, 2=2, etc., and then summing across all 10 items, a higher score indicates more perceived stress.

    Measured: 3 Months

Secondary outcomes (2)
  1. Resilience

    Connor-Davidson Resilience Scale (CD-RISC) which was developed Kathryn and Jonathan, (2003). The Connor-Davidson Resilience Scale (CD-RISC) comprises 25 items that measure resilience or capacity to change and cope with adversity. Respondents indicated their response on a 5-point Likert scale with higher scores indicating greater resilience. Scoring criteria: As for the scoring system of the CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience.

    Measured: 3 Months

  2. Sexual Satisfaction

    Sexual Satisfaction Index (SSI) which was developed by Leth-Nissen and colleagues, (2021). There were nine items in this edition of the SSI: five positive items (items 1, 2, 3, 8, and 9) and four negative ones (items 4, 5, 6, and 7). Every item is scored on a 5-point rating system, with the negative ratings being reversed and ranging from 1 (strongly disagree) to 5 (strongly agree). The SSI's total score falls between 1 and 45. A greater level of sexual satisfaction is indicated by a higher sum score.

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start15 Jan 2024
  3. Primary completion30 Mar 2024
  4. Study completion21 Jul 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583629
Sponsor's protocol ID
FMBSUREC/03122023/ Mohamed
Status last verified
Aug 2024
First submitted
28 Aug 2024
Last updated
4 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mohamed AF, Hamed AEM, Mohamed SSA, Othman AA, El-Tawab NAA. Effect of nursing application of emotion freedom technique on perceived stress, resilience and sexual satisfaction among women after mastectomy. BMC Nurs. 2025 Apr 15;24(1):428. doi: 10.1186/s12912-025-02977-2.

    PubMed 40234881

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Freedom Technique in people with Stress and Sexual Satisfaction, run by Helwan University at 1 site in Egypt.

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 3 inclusion and 3 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 4 Sep 2024. 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 Egypt. 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. 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?

Perceived Stress (time frame: 3 Months). 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 NCT06583629, 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 4 Sep 2024.

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